In this INSIDER Q&A, experts in contract manufacturing discuss aspects a brand owner should evaluate, what should be outlined in an agreement and what ongoing QA checks to conduct during the partnership.

The best sports nutrition formulas designed to improve performance draw from a pool of ingredients researched for benefits to energy production, cognitive function and endurance both in general and specifically concerning muscles.

A doctor, researcher and former chronic migraine sufferer, has launched her own biotech startup company named KetoSwiss selling supplements that she argues can help control migraine pain by tapping into our own biological mechanisms.

It is "inconceivable" that immunity will not remain high on the list of health priorities when this pandemic ends and now is the time to create more "convincing experiences" to ensure trial turns into adoption, according to food and drink research and branding experts.

French beauty supplement firm D+ For Care has launched a mouth spray to aid sleep and has a flurry of holistic wellbeing innovation primed for 2020 â the year nutricosmetics could really take off, its founder says.

In scenic Puerto Varas, APEC delegates engaged in constructive dialogue about how to adopt to a changing world.

APEC continues to bolster ethics in the healthcare sector in support of small and medium enterprises (SMEs) and patients, as Chile launches a consensus framework to improve ethical interactions in its healthcare system.

Ministers in charge of women’s economic participation in the APEC region issued a joint statement following their meeting in La Serena, Chile, on 4 October 2019.

APEC member economies launched the APEC Women in STEM Principles and Actions, a set of suggested principles and actions for encouraging women’s participation in the fields of science, technology, engineering, and mathematics, commonly referred to as STEM.

From : Communities>>Regulatory Open Forum
Yes, I think there were some previous posts where people uploaded Word versions you can get; just need to look around a little. ------------------------------ Richard Vincins RAC Vice President Global Regulatory Affairs ------------------------------

From : Communities>>Regulatory Open Forum
Hello Jose, To my knowledge, the change of O/O does not trigger a notification that needs to be confirmed, nor does it trigger a review of enforcement history.  The change of ownership and O/O is merely an administrative update that gives FDA both current information and a history of changes.  Of course, if there are known red flags with any of the involved organizations, changes can be scrutinized. Regards, James ------------------------------ James Bonds J.D. Director Regulatory Affairs Atlanta [More]

From : Communities>>Regulatory Open Forum
Hi everyone, I just finished it, and it is a really simple task! Go ahead! Thanks Anna --------------------------------- Anna Alonzi MD Sr. Regulatory Associate Newtown PA United States ---------------------------------

From : Communities>>Regulatory Open Forum
This message was posted by a user wishing to remain anonymous Why not use Adobe to fill out the form?  You will need it to compile the submission anyway.

From : Communities>>Regulatory Open Forum
Thank you all for participating in our Tagging Project! We're glad to hear you enjoyed it. All volunteers were entered into a drawing for a $50 Amazon gift card. See a video of the drawing attached.  I'm happy to announce that the winner is ...  @Jonathan Amaya-Hodges ! Thanks again to all who participated. If you're interested in more volunteer opportunities, see our full list here .​​ ------------------------------ Danielle Fezell Manager, Chapter & Volunteer Relations, RAPS Rockville MD United [More]

Files Attached Document
RE: Sort It Out by participating in the RAPS Tagging Project

From : Communities>>Regulatory Open Forum
Thank you RAPS, what a pleasant surprise! I appreciate the opportunity to contribute to the project! Now, if only Amazon had any toilet paper in stock... ------------------------------ Jonathan Amaya-Hodges Associate Director, Regulatory Affairs CMC Combination Products and Medical Devices Cambridge MA United States ------------------------------

From : Communities>>Regulatory Open Forum
This message was posted by a user wishing to remain anonymous When this was first issued we printed it out, filled in the answers with careful handwriting and then scanned it back in - which seemed to be perfectly acceptable. Since then we've converted their form to a fillable PDF.​

You know you need a computer systems audit, but that’s literally the extent of what you know.
Has this ever been you?

Yes, you use computers on a daily basis, and you may even use the system that needs to be audited. But you don’t spend your day thinking about where all the system components are located, how services and software are combined, and what Part 11 requirements apply. Terms like “cloud computing” make you feel slightly queasy. You’d rather get a root canal than discuss “distributed processing.” Your expertise is in manufacturing. Or clinical research. Or non-clinical lab operations. And somehow it’s your job to make sure an effective and properly-sized system audit is conducted. Great.



Yet your Quality Assurance colleagues -- whether they’re from your internal QA department or an external compliance company -- need your input. They need to understand what software is being purchased, what services are being contracted, how and where components of the system are being implemented, and how the system will be used.

The good news is that the QA auditors can help you. They know that FDA favors a risk-based approach to validation and Part 11 implementation, and they even know what that means. They love to talk about configuration management and change procedures. They love gathering evidence that demonstrates your system works correctly and is in a state of control, and they know what rocks they should look under to find and fix vulnerabilities.

What follows are examples of the types of information you need to convey to QA – and that they should be asking you about – to properly size and scope an audit.

How do You Plan to Use the System?

Suppose you need to audit the supplier of a new Document Management System. The first thing an auditor would need to understand is how you plan to use the system. How mission critical are the documents you’re looking to store?  Are they covered under regulatory scope?  Maybe you plan to use the system as a collaboration environment for developing new SOPs. That would require a relatively low level of scrutiny, especially if you only plan to print out the finalized documents for wet ink signature. (As a point of comparison, if you plan to use the system to finalize SOP approval, the auditor would need to check that Part 11 requirements for electronic signatures are properly implemented.) What if the Document Management System will be housing critical GxP documents, such as Trial Master Files, Master Schedule Sheets, or Master Batch Records? In these cases, the validation would have to be far more thorough, and Part 11 electronic record features, such as audit trails and archiving functionality, would have to be implemented and verified.

Here’s another “use” example. Similar to the term “Document Management System,” the term “Analytics System” does not tell the whole story. From a business perspective, study start up (SSU) metrics may be vital for sponsors and CROs to collect and analyze. But since they have no regulatory impact, the FDA would not require an SSU analytics system to be validated. (That doesn’t necessarily mean you might not want to, though.) On the other hand, a system that performs statistical analysis on study data for regulatory submission is about as critical as it gets, and would require thorough validation and Part 11 implementation. Other analytics systems, such as dashboards that pull data from critical systems, might fall somewhere between these two extremes.

What is the Vendor Providing? And How? And Where?

If you need to audit a complex system, the questions QA will ask you will go beyond system use. The auditors will need to understand the combination of software and services the vendor is providing, and where the software and data reside.

• Does the software and data reside internally at your company or does the vendor provide a hosting service?
  If the vendor is hosting, the auditor needs to tour the facilities and review SOPs and records to evaluate physical security, staff training, environmental controls, backup procedures, disaster recovery plans, data retention, computer infrastructure, and change control.
  
  
• Does the hosting vendor own its own servers or does it, in turn, outsource that function to a 3rd party hosting company, (possibly even in the cloud)?
  If the hosting is outsourced, ideally an auditor would be able to visit the hosting site. Failing that, the auditor would ask questions about the vendor’s qualification processes and review SOPs that govern vendor selection/management procedures. If the vendor outsources other services beyond hosting, those services might need to be considered, as well.
  
  
• Is the vendor providing any other services?
  Many EDC vendors will provide study-specific services such as screen development and data entry validation edits. Auditors would need to review SOPs for providing these services and understand how the vendor tests and manages modifications to these components as the study proceeds.
  Sometimes computer systems vendors provide ancillary services, such as help desk functions and user account management. That would mean additional SOPs and training records for the auditor to look through.

Other Considerations

There are many. For example, where are you in the product life cycle? You ask different questions about a new system than you would about one that has been operating for a few years. Is the product Commercial off-the-shelf (COTS) or highly customized? COTS systems vendors often have their own validation package which auditors would review, and then ensure proper operation in the sponsor/CRO’s specific environment. A highly customized or custom-built system would require a more extensive validation process.


The Take Away

CSV/Part 11 audits will never be standardized, cookie cutter type activities; there are simply too many factors -- in too many combinations -- to consider. You want your QA efforts to be worth the money you spend and be able to answer the questions FDA says you need to be asking. If you’re unsure how to do that, that’s ok. Other people know, as long as you can help them understand how you plan to use the system, what software and services are being supplied, and how components of the system are being implemented.

In case you missed it, our previous post was Notes 2 Fix Your Notes 2 File.
_______________________________________________
Many thinks to Lisa Olson for sharing her insights with me.

Vertex Pharmaceuticals announced a plan late Tuesday to begin trials before the end of the year of the third in its so-called “triple combo” of pills designed to treat as much as 90 percent of the 75,000 patients worldwide who suffer from cystic fibrosis. That news, announced in conjunction with the Boston-based drugmaker’s third-quarter financial results last night, spurred a 6 percent stock increase after hours, implying the company’s market cap could increase by about half a billion dollars…

On Friday, 21 emerging medical device companies will present their technologies and business plans to a group of local investors at the annual MedTech Showcase, hosted by the Massachusetts Medical Device Industry Council. More than 300 venture leaders and business leaders are expected to attend the event tomorrow, Oct. 28 from 8 a.m. to 2 p.m. at the Westin Waltham, 70 Third Ave. As a main event, John McDonough, president and CEO of Lexington-based T2 Biosystems (Nasdaq: TTOO), will be interviewed…

Third Rock Ventures, the Boston-based venture capital firm behind some of the Bay State’s most prominent biotechs, has reclaimed its title as the biggest life science-focused VC firm in the state with a new $616 million round, and has also named its first female partner in eight years. With the announcement of its Fund IV today — its largest ever — the firm now has raised $1.9 billion in the nine years since it was formed. That eclipses its rival across the Charles River, Flagship Ventures,…

Do we ever learn from our past mistakes? For many years we believed that technology was an inevitable force for good. It would give us instant access to a near infinite amount of information and allow us to easily and instantly connect with nearly anyone on earth. What could go wrong? The answer is that...

Click here to continue reading...

WASHINGTON, D.C. – Five lawmakers introduced a bipartisan bill giving a full range of medical services to families with children who have life-limiting illnesses and who qualify for Medicaid, which currently has gaps in such coverage.

The Children’s Program of All-Inclusive Coordinated Care (ChiPACC) Act (H.R. 6560) would let states create comprehensive care programs for these children. Its authors are the Co-Chairs of the Congressional Childhood Cancer Caucus: Representatives Michael McCaul (R-TX), Jackie Speier (D-CA), G.K. Butterfield (D-NC), and Mike Kelly (R-PA), together with Representative Diana DeGette (D-CO), a senior member of the House Energy and Commerce Committee.

“Families with children facing life-limiting illnesses need all the support they can get, and they should be empowered to seek out that support,” the bill’s sponsors said in a joint statement. “We owe it to these kids and their loved ones to help ensure more compassionate care in their most trying times.”

Gaps in Medicaid coverage of hospice and palliative services have deprived many beneficiaries of the care they need because the program does not cover some of children’s unique medical needs.

Under this bill, the family of every child who qualifies for Medicaid will receive a specialized care plan covering a range of services – palliative, counseling, respite, expressive therapy and bereavement – providing them and their families greater comfort and peace of mind.

###

 

The WHO and world leaders commit to a fund to accelerate development of vaccines, tests and treatments for COVID-19.

Under the agreement, AZ will develop, manufacture and distribute the vaccine that has already begun Phase I trials.

Earlier this month I published a blog posting that raised questions related to the potential for disruption of approvals in the wake of FDA actions to limit inspections due to the COVID-19 pandemic. Subsequently I had the opportunity to pose … Continue reading →

With the COVID-19 impact making itself apparent on a daily basis as the numbers climb and organizations respond, the effects on the pharma and biotech sector also shifts. Yesterday FDA announced a new concentration of agency assets to be focused … Continue reading →

Virtually everyone is going virtual. Even in February, which seems like a very long time ago, many organizers began either postponing or canceling major conferences and meetings. This has included major medical meetings and given that large gatherings will be … Continue reading →

In response to written questions submitted last month regarding the potential for delays, FDA had stated that “CDER remains fully capable to continue daily activities, while responding to the public needs of the current COVID-19 outbreak.” In a subsequent blog … Continue reading →

by Derek Willis

In an April report that warns of the risks of fraud in mail-in voting, a conservative legal group significantly inflated a key statistic, a ProPublica analysis found. The Public Interest Legal Foundation reported that more than 1 million ballots sent out to voters in 2018 were returned as undeliverable. Taken at face value, that would represent a 91% increase over the number of undeliverable mail ballots in 2016, a sign that a vote-by-mail system would be a “catastrophe” for elections, the group argued.

However, after ProPublica provided evidence to PILF that it had in fact doubled the official government numbers, the organization corrected its figure. The number of undeliverable mail ballots dropped slightly from 2016 to 2018.

The PILF report said that one in five mail ballots issued between 2012 and 2018, a total of 28.3 million, were not returned by voters and were “missing,” which, according to the organization, creates an opportunity for fraud. In a May 1 tweet that included a link to coverage of the report, President Donald Trump wrote: “Don’t allow RIGGED ELECTIONS.”

PILF regularly sues state and local election officials to force them to purge some voters from registration rolls, including those it claims have duplicate registrations from another state or who are dead. It is headed by J. Christian Adams, a former Justice Department attorney who was a member of the Trump administration’s disbanded commission on election integrity.

The report describes as “missing” all mail ballots that were delivered to a valid address but not returned to be counted. In a statement accompanying the report, Adams said that unaccounted-for ballots “represent 28 million opportunities for someone to cheat.” In particular, the organization argues that the number of unreturned ballots would grow if more states adopt voting by mail.

Experts who study voting and use the same data PILF used in the report, which is from the Election Administration and Voting Survey produced by the federal Election Assistance Commission, say that it’s wrong to describe unreturned ballots as missing.

“Election officials ‘know’ what happened to those ballots,” said Paul Gronke, a professor at Reed College, who is the director of the Early Voting Information Center, a research group based there. “They were received by eligible citizens and not filled out. Where are they now? Most likely, in landfills,” Gronke said by email.

A recent RealClear Politics article based on the PILF report suggested that an increase in voting by mail this year could make the kind of fraud uncovered in North Carolina’s 9th Congressional District in 2018 more likely. In that case, a political consultant to a Republican candidate was indicted on charges of absentee ballot fraud for overseeing a paid ballot collection operation. “The potential to affect elections by chasing down unused mail-in ballots and make sure they get counted — using methods that may or may not be legal — is great,” the article argues.

PILF’s report was mentioned in other news outlets including the Grand Junction Sentinel in Colorado, “PBS NewsHour” and the New York Post. The Washington Times repeated the inaccurate claim of 1 million undeliverable mail ballots.

In a statement, the National Vote at Home Institute, an advocacy group, challenged the characterization of the 28.3 million ballots as missing. Of those ballots, 12 million were mailed by election officials in Colorado, Oregon and Washington, which by law send a mail-in ballot to every registered voter, roughly 30% of which are not returned for any given election. “Conflating voters choosing not to cast their ballots with ‘missing’ ballots is a fundamental flaw,” the statement reads.

In an interview, Logan Churchwell, the communications director for PILF, acknowledged the error in the number of undelivered ballots, but defended the report’s conclusions, saying that it showed potential vulnerabilities in the voting system. “Election officials send these ballots out in the mail, and for them to say ‘I have no idea what happened after that’ speaks more to the investments they haven’t made to track them,” he said in a telephone interview.

But 36 states have adopted processes where voters and local officials can track the status of mail ballots through delivery, much like they can track packages delivered to a home. Churchwell said there are other explanations why mail ballots are not returned and that state and local election officials could report more information about the status of mail ballots. “If you know a ballot got to a house, you can credibly say that ballot’s status is not unknown,” he said.

The EAVS data has been published after every general election since 2004, although not every local jurisdiction provides complete responses to its questions.

In the data, election officials are asked to provide the number of mail ballots sent to voters, the number returned to be counted and the number of ballots returned as undeliverable by the U.S. Postal Service, which provides specific ballot-tracking services. The survey also asks for the number of ballots that are turned in or invalidated by voters who chose to cast their ballots in person. It asks officials to report the number of ballots that do not fit into any of those categories, or are “otherwise unable to be tracked by your office.”

Gronke described the last category as “a placeholder for elections officials to put numbers so that the whole column adds up,” and said that there was no evidence to support calling those ballots a pathway to large-scale voter fraud.

Numerous academic studies have shown that cases of voter fraud are extremely rare, although they do occur, and that fraud in mail voting seems to occur more often than with in-person voting.

by ProPublica

The Pulitzer Board announced Monday that two series published by ProPublica were awarded Pulitzer Prizes. “Lawless,” a ProPublica Local Reporting Network project by the Anchorage Daily News that revealed how indigenous people in Alaska are denied public safety services, was awarded the prize for public service. “Disaster in the Pacific,” an investigation on the staggering leadership failures that led to deadly accidents in the Navy and Marines, won a national reporting prize. The two designations are ProPublica’s 6th Pulitzer win in 12 years and the first Pulitzer awarded to a Local Reporting Network partner.

Led by Daily News reporter Kyle Hopkins, “Lawless” was the first comprehensive investigation to lay bare Alaska’s failing, two-tiered justice system in which Native villages are denied access to first responders. In much of rural Alaska, villages can only be reached by plane, and calling 911 to report an emergency often means waiting hours or days for help to arrive.

The series evolved from a string of stories that Hopkins reported in 2018 for the Daily News, recounting horrific incidents of sexual assault in Alaska — which has the nation’s highest rate of sexual violence — and policing failures that have allowed offenders to continue the abuse with impunity. To fully investigate issues of lawlessness and sexual assault in the most remote communities in the U.S., the Daily News applied to participate in ProPublica’s Local Reporting Network. The program partners with newsrooms across the country, paying the salary and a stipend for benefits for local reporters who spend a year tackling big investigative stories that are crucial to their communities. Participating reporters work with a ProPublica senior editor and receive support, including from ProPublica’s data, research and engagement teams.

The collaboration’s first story, based on more than 750 public records requests and interviews, found that one in three rural Alaska communities has no local law enforcement of any kind. These indigenous communities are also among the country’s most vulnerable, with the highest rates of sexual assault, suicide and domestic violence. The series’ second major installment found that dozens of Alaska communities, desperate for police of any kind, hired officers convicted of felonies, domestic violence, assault and other offenses that would make them ineligible to work in law enforcement or even as security guards anywhere else in the country.

Next, Hopkins revealed how the state’s 40-year-old Village Public Safety Officer Program, designed to recruit villagers to work as life-saving first responders, has failed by every measure. Alaska had quietly denied funding for basic recruitment and equipment costs for these unarmed village officers while publicly claiming to prioritize public safety spending. “Lawless” also exposed how the Alaska State Troopers agency, created to protect Alaska Native villages, instead patrols mostly white suburbs surrounding cities on the road system like Wasilla. The series ended with a list of six practical solutions to Alaska’s law enforcement crisis, based on interviews with experts, village leaders, the Alaska congressional delegation and sexual assault survivors.

The Daily News and ProPublica faced a number of challenges in reporting the series. The first: No one knew which remote Alaska villages had police officers of any kind. So they built the first-ever statewide policing database by drawing on payroll, arrest and hiring records from communities spread across the state. They also contacted every village city government, sovereign tribal administrator and Alaska Native corporation in the state — more than 600 organizations.

The vastness of the state and the fact that 80% of communities aren’t on the road system posed another challenge. Journalists flew hundreds of miles, sleeping on the floors of schoolhouse libraries and riding in sleds and on snowmobiles. To aid the reporting, they also held a community meeting in Kotzebue, Alaska, where a 10-year-old girl had been raped and murdered in 2018, providing residents, advocates, tribal leaders and law enforcement their first chance for a public discussion on sexual violence. Throughout the year the reporters spoke to more than 300 people across the state.

Following publication of the first major story, U.S. Attorney General William Barr visited the state and declared the lack of law enforcement in rural Alaska to be a federal emergency. The declaration led the Department of Justice to promise more than $52 million in federal funding for public safety in Alaska villages. The U.S. Attorney’s Office in Anchorage announced the hiring of additional rural prosecutors, while Gov. Mike Dunleavy said the state will post 15 additional state troopers in rural Alaska. In addition, the Alaska Police Standards Council has proposed changing state regulations that govern the hiring and screening of village police officers, and Alaska legislators proposed legislation that would increase pay for VPSOs and overhaul funding of the program.

The Daily News’ Loren Holmes, Bill Roth, Marc Lester, David Hulen, Anne Raup, Vicky Ho, Alex Demarban, Jeff Parrott, Michelle Theriault Boots, Tess Williams, Tegan Hanlon, Zaz Hollander, Annie Zak, Shady Grove Oliver and Kevin Powell, as well as ProPublica’s Charles Ornstein, Adriana Gallardo, Alex Mierjeski, Beena Raghavendran, Nadia Sussman, Lylla Younes, Agnel Philip, Setareh Baig and David Sleight also contributed to the series.

“The ProPublica Local Reporting Network was started to give local newsrooms across America the resources and support they need to execute investigative journalism that digs deep and holds power to account,” Ornstein, a ProPublica deputy managing editor, said. “This powerful collaboration with the Anchorage Daily News investigation does exactly that, going far beyond reporting on isolated incidents to provide meticulous research and context on how the justice system has failed Alaska’s most remote and vulnerable communities. Most importantly, it has been a force for real change.”

In their “Disaster in the Pacific” series, ProPublica reporters T. Christian Miller, Megan Rose and Robert Faturechi centered on three deadly accidents in the Navy and Marines in 2017 and 2018. They exposed America’s vaunted 7th Fleet as being in crisis with broken ships and planes, poor training for and multiple warnings ignored by its commanders. The costs: 17 dead sailors in crashes involving Navy warships, and six Marines killed in a training accident.

The back-to-back accidents in 2017 and 2018 gained initial attention from Congress and the national media, but they had been told an incomplete, misleading and dangerous story of half-truths and cover-ups. ProPublica’s series provided the first full accounting of culpability, tracing responsibility to the highest uniformed and civilian ranks of the Navy. The reporting team spent 18 months on the investigation, obtaining more than 13,000 pages of confidential Navy records and interviewing hundreds of officials up and down the chain-of-command.

The first article in the series, “Fight the Ship,” reconstructed a 2017 crash involving the USS Fitzgerald, one of the deadliest accidents in the history of the Navy. The story showed that the accident was entirely preventable, and that the Navy’s senior leadership had endangered the warship by sending a shorthanded and undertrained crew to sea with outdated and poorly maintained equipment. To show readers what happened, ProPublica hired designer Xaquín G.V. Working with investigations producer Lucas Waldron, Xaquín used geodata on the ships’ locations, mapped the path of each vessel and created a graphic that simulated the crash, down to the moment the Fitzgerald was sent spinning out of control, rotating 360 degrees. The team also collected radar images, ship blueprints, hand-drawn images made by surviving sailors and video taken inside the ship, which allowed them to portray the disaster from the perspective of the sailors onboard.

A second story, “Years of Warnings, Then Death and Disaster,” detailed how the fatal crash of the USS Fitzgerald, and of the USS McCain weeks later, were the result of a congressional gutting of the Navy and the Navy’s prioritization of building new ships. Top Navy officials gave urgent, repeated warnings to Navy Secretary Ray Mabus about the deadly risks facing its fleet, including being short of sailors, sailors poorly trained and worked to exhaustion, warships physically coming apart, and ships routinely failing tests to see if they were prepared to handle warfighting duties. They were ignored, told to be quiet or even ordered to resign.

Another story captured the Marine Corps multiple failures that were responsible for the deaths of six men in a nighttime training exercise 15,000 feet above the Pacific — an accident that senior leaders had been warned was possible, even likely. ProPublica created an animated short documentary, using a combination of an on-camera interview, 3D animation, 2D illustration and atmospheric footage to bring the excruciating hours of a needless tragedy to light. Through extensive interviews with eyewitnesses, the team reconstructed the moments leading up to the crash, the crash itself and the botched search and rescue effort.

The series also illuminated how the Navy’s reckless management of the 7th Fleet was measured not only in fatalities, but also in the hurt and shame of the rank-and-file sailors whom the Navy blamed and prosecuted for the accidents. The Navy’s prosecution of Navy Cmdr. Bryce Benson for what were clearly systemic shortcomings, traceable all the way to the Pentagon, left many of its own furious and demoralized.

Weeks after the first story’s publication, the House Armed Services Committee convened a panel to challenge senior Navy leaders over their claims that they had been fully truthful about its failings and its efforts at reform. The reporting forced the Navy to admit to Congress that its claims about its rate of progress on reform were misleading. In light of ProPublica’s reporting on the improper role that the Navy’s top commander played in the prosecution of Benson, one of captains on the USS Fitzgerald, the Navy dropped all criminal charges. U.S. and NATO Navy commands throughout the world have ordered sailors and officers to read the ProPublica accounts as part of training and education.

Joseph Sexton, Tracy Weber, Agnes Chang, Katie Campbell, Joe Singer, Kengo Tsutsumi, Ruth Baron, David Sleight, Sisi Wei, Claire Perlman, Joshua Hunt and Nate Schweber also contributed to this series.

“The Navy actively blocked reporting at every step, with communications officers attempting to dissuade officials from conducting interviews with ProPublica and leaking positive stories to competing media outlets in an attempt to front-run our stories,” ProPublica Managing Editor Robin Fields said. “The military even threatened that we could be criminally prosecuted for publishing the material we obtained. This tour de force of investigative journalism is a testament to the unflinching tenacity of the reporters and the innovation of ProPublica’s data, graphics, research and design teams. Their essential work laid bare the avoidance of responsibility by the military’s most senior leaders.”

by Annie Waldman

Last September, over pancakes at a diner in central Massachusetts, Molly Baldwin told her husband, Jonathan, they were going to have a baby. He cried into his coffee mug, elated and a little surprised. They had only been trying for about a week, and they had yearned for a summer baby, ideally in June, which would enable their parents to spend more time with their first grandchild.

“We thought we had the best timing,” she said.

But as the novel coronavirus began to spread through the country this year, Baldwin realized in early March that it was only a matter of time before the virus hit her town, Fitchburg, and the nursing home where she’s a social worker. Her patients would be among the most vulnerable: Some had battled addiction, many had experienced homelessness and most were elderly. Flu seasons were always hard on her patients, and she dreaded the havoc a more lethal disease would wreak.

Baldwin also worried about her baby. She spent hours looking up the prenatal effects of COVID-19, and the lack of evidence-based research concerned her. She called her obstetrician, who cautioned that because of the unknowns, she should consider working from home to limit her exposure to the virus.

So Baldwin made a plan for when COVID-19 arrived at her nursing home: She would swap shifts with a colleague to work fewer hours and request to work from home, as many of her duties are paperwork or computer-based.

She would work from the comfort of her kitchen table. She would avoid catching the virus. She would keep visiting her doctor until it was time to deliver, her belly swelling with a baby girl she knew was healthy and safe.

None of it, not a single thing, would go according to plan.

Baldwin said her supervisor and the human resources representative from the facility verbally agreed in mid-March to let her work from home. (Baldwin spoke with ProPublica on the condition that her workplace not be named; ProPublica contacted her employers with questions for this story.)

Then, on April 16, one of the residents at her facility tested positive for the virus. Baldwin sought testing at a walk-in clinic, and the results came back negative. But when she called her obstetrician’s office, she got a warning: If she continued to work at the facility, potentially exposing herself to the virus, they would not allow her to enter their office for prenatal appointments unless she could prove with a test, before each visit, that she was negative for COVID-19.

She understood their caution; her job was beginning to feel at odds with her pregnancy. It was time for her work-from-home plan to go into action.

She called her employer and asked to start the accommodations she had requested the month before. But they told her that now the plan would not be feasible, she said. Other pregnant employees were continuing to work at the facilities, and she would have to as well, she said she was told.

“The services provided at a nursing home do not typically allow for remote working,” a company spokesperson told ProPublica. “However, we have made changes to accommodate our staff whenever possible, provided there is no impact on patient care.”

After finding out her request to work from home would not be granted, Baldwin panicked. “I’m not even a mom yet,” she said. “This is my first baby, and I already feel like I’m doing everything wrong.”

---

Baldwin is one of dozens of pregnant workers who ProPublica has heard from who are navigating the risks of COVID-19 while in the field of health care.

“There are plenty of pregnant women across the country who are trying to figure out what to do to protect themselves, given the uncertainty,” said Emily Martin, vice president for education and workplace justice at the National Women’s Law Center. “If you feel like you can’t do your job because there aren’t certain accommodations and you feel like you’re at risk, it’s difficult to see where to go next.”

About half of the states have laws that allow pregnant women to request reasonable accommodations, including Massachusetts, Martin said.

According to the Massachusetts Pregnant Workers Fairness Act, signed into state law in July 2017, employers must grant reasonable accommodations to their pregnant employees that allow them to continue to do their job, “unless doing so would impose an ’undue hardship’ on the employer.” An employer also “cannot make an employee accept a particular accommodation if another reasonable accommodation would allow the employee to perform the essential functions of the job.”

Both the Centers for Disease Control and Prevention and the American College of Obstetricians and Gynecologists have stated that based on the data available, pregnant women do not face a higher risk of infection or severe morbidity related to COVID-19. That said, both the CDC and ACOG have suggested that health care facilities may want to consider reducing the exposure of pregnant health care workers to patients with confirmed or suspected COVID-19, if staffing permits.

“In the overwhelming majority of pregnancies, the person who is pregnant recovered well with mild illness,” said Dr. Neel Shah, an obstetrician and assistant professor at Harvard Medical School, echoing the current guidance. But, he cautioned, there is a lot we still don’t know about how the virus impacts bodies, let alone those that are pregnant. “We can’t say that it’s completely safe — we don’t know.”

---

Baldwin and her husband went through their options.

She couldn’t quit because they needed her paycheck. They had a mortgage, student loans and a new baby on the way. She also loved her job and cared deeply for her patients, whom she wanted to continue to serve. Her employer, trying to manage understaffing, had discouraged employees from taking time off, she said. She didn’t want to take any additional sick days, because she needed to save them for her maternity leave.

They decided that she would have to return to work.

Her employer told her to wear a mask and gloves, use hand sanitizer and remain in her small, boxy office, which has three desks for four people. Though she didn’t have contact with the residents, her office mates still did.

Even though she was scared, she tried to stay optimistic. “I was grateful for what I had because I have friends that are out of work right now,” she said. But she remained perplexed about why her requests had been denied. “I was sitting in my office doing work that would have easily been done from a laptop on my kitchen table.”

The company spokesperson did not respond to a question about whether it had originally given Baldwin verbal approval to work from home. When asked why she couldn’t have done the same work remotely, he said, “Based on your questions, our HR and Risk Management are anticipating action and would prefer to not comment at all.”

The next day, the Massachusetts National Guard delivered testing kits to the nursing home, and every resident was checked for the virus. When the results came back, at least 22 residents and 20 other staff members tested positive.

“We are conducting cleanings and infection control measures multiple times per day, with extra focus on high touch areas,” the company spokesperson said. “We screen and take the temperature of anyone entering our building, and we have increased monitoring of our residents.”

Public data shows the facility has more than 30 cases among residents and staff, the maximum number that the state reports publicly.

“I thought if I just keep working, stay in my office, use hand sanitizer, wear my mask, go home and shower right away, disinfect my clothes, then I will be fine, and I can keep my baby safe, and I can shed all this guilt,” she said.

Then on April 24, two of her office mates texted to tell her they had the virus.

And that morning, she’d felt a tickle in her throat.

---

“I know I’m positive,” she thought to herself, as she left work midday and drove to a CVS drugstore testing site an hour away that was offering free rapid tests for front-line and health care workers. Hundreds of cars were already lined up.

She waited alone in her Jeep Wrangler for three hours, wearing her mask as required, which muffled her nagging cough. She shifted around constantly, to keep blood from pooling in her swelling feet. At the front of the line, she received a 6-inch cotton swab, wedged it deep in her nasal cavity, and returned it to the technicians. They directed her into a side parking lot, and 30 minutes later, she got a phone call with her results.

“We’re sorry to tell you that you’re positive,” the voice on the line told her. Baldwin’s mind stalled, engulfed in a wave of anxiety, which gave way to seething frustration.

“This was so preventable,” she said. “Now here I am, 33 weeks pregnant and positive. My most important job is to keep the baby safe, and my actual job wasn’t making that happen.”

When she called her co-workers and supervisor to tell them she tested positive, she said they were “all very caring and compassionate.” They told her to stay home for at least a week, or until her symptoms subsided. The Families First Coronavirus Response Act requires most employers to provide their workers with two weeks of paid leave if the employee is quarantined or experiencing COVID-19 symptoms. Baldwin said she would have to exhaust her sick days first; she’d been saving them for her maternity leave. Her husband, who works as a correctional officer at a county jail, was allowed to take 14 days of paid leave to tend to his wife, without using his own sick days.

She could no longer go to her normal obstetrician for in-person appointments, and instead, she would have to rely on telemedicine. Her doctor connected her with an obstetrician specializing in COVID-19 cases, with whom she planned to meet this week.

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Last Saturday, Baldwin’s mother had planned to throw her daughter a baby shower. She had invited 50 of their closest friends to celebrate at a new restaurant and had ordered dozens of pink favors from Etsy.

Because of the stay-at-home order, her shower morphed into a drive-by celebration, where her friends and family passed by her house, honking their horns and holding celebratory signs, balloons and streamers. They dropped gifts in front of her house, including first aid kits and a handsewn pink mask for an infant.

Her symptoms have, so far, been relatively mild, similar to a normal flu: headaches, a stuffy nose, a sore throat and muscle pains. She’s spent most of the past week resting in bed and taking baths to soothe her body aches. While taking care of Baldwin, her husband has also contracted the virus and is experiencing severe body aches as well.

In addition to her disappointment that the hypnobirthing and breastfeeding classes she had signed up for are canceled, her time in quarantine is now filled with anxious questions about how the disease may impact her baby.

Will the stress of this experience damage her baby neurologically? Will her baby be born early? Will she have to deliver by cesarean section to relieve pressure on her body and lungs, like so many stories she had read? Will she have to be secluded from her baby for days or weeks after birth? And what if her own symptoms worsen?

“This is our first baby, and it was so planned and wanted,” she said. “But had we known this awful thing would happen, would we have tried when we did?”

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by J. David McSwane

The Transportation Security Administration ignored guidance from the Department of Homeland Security and internal pushback from two agency officials when it stockpiled more than 1.3 million N95 respirator masks instead of donating them to hospitals, internal records and interviews show.

Internal concerns were raised in early April, when COVID-19 cases were growing by the thousands and hospitals in some parts of the country were overrun and desperate for supplies. The agency held on to the cache of life-saving masks even as the number of people coming through U.S. airports dropped by 95% and the TSA instructed many employees to stay home to avoid being infected. Meanwhile, other federal agencies, including the Department of Veterans Affairs’ vast network of hospitals, scrounged for the personal protective equipment that doctors and nurses are dying without.

“We don’t need them. People who are in an infectious environment need them. Nobody is flying,” Charles Kielkopf, a TSA attorney based in Columbus, Ohio, told ProPublica. “You don’t take things for yourself. It’s the wrong thing to do.”

Kielkopf shared a copy of an official whistleblower complaint he filed Monday. In it, he alleges the agency had engaged in gross mismanagement that represented a “substantial and specific danger to public health.”

TSA has not required its screeners to wear N95s, which require fitting and training to use properly, and internal memos show most are using surgical masks, which are more widely available but are less effective and lack the same filtering ability.

Kielkopf raised a red flag last month about the TSA’s plan to store N95 respirators it had been given by Customs and Border Protection, which found more than a million old but usable masks in an Indiana warehouse. Both agencies are overseen by DHS. That shipment added to 116,000 N95s the TSA had left over from the swine flu pandemic of 2009, a TSA memo shows. While both stockpiles were older than the manufacturer’s recommended shelf life, the Centers for Disease Control and Prevention said that expired masks remain effective against spreading the virus.

Kielkopf and another TSA official in Minnesota suggested that the agency send its N95 masks to hospitals in early April, records show. Instead, TSA quietly stored many of them in its warehouse near the Dallas-Fort Worth airport and dispersed the rest to empty airports across the nation.

“We need to reserve medical masks for health care workers,” Kielkopf said, “not TSA workers who are behind an X-ray machine.”

The Number of Travelers Passing TSA Checkpoints Has Dropped to Historic Lows

The TSA didn’t provide answers to several detailed questions sent by ProPublica, but spokesman Mark Howell said in an email that the agency’s “highest priority is to ensure the health, safety and security of our workforce and the American people.”

“With the support of CBP and DHS, in April, TSA was able to ensure a sufficient supply of N95 masks would be available for any officer who chose to wear one and completed the requisite training,” the statement read.

“We are continuing to acquire additional personal protective equipment for our employees to ensure both their and the traveling public’s health and safety based on our current staffing needs, and as supplies become available,” TSA said.

A review of federal contracting data shows the agency has mostly made modest purchases such as a $231,000 purchase for gallons of disinfectant, but has not reported any new purchases of N95s.

An internal TSA memo last month said the surplus of N95s was expected to last the agency about 30 days, but the same memo noted that estimate did not account for the drastic decline in security officers working at airports. ProPublica asked how long the masks were actually going to last, accounting for the decreased staffing levels.

“While we cannot provide details on staffing, passenger throughput and corresponding operations have certainly decreased,” the TSA statement said.

The trade journal Government Executive reported this week that internal TSA records showed most employee schedules have been “sharply abbreviated,” while an additional 8,000 security screeners are on paid leave over concerns that they could be exposed to the virus.

More than 500 TSA employees have tested positive for COVID-19, the agency reported, and five have died.

The CDC has not recommended the use of N95s by TSA staff, records show, but that doesn’t mean workers who have or want to wear them can’t.

In one April 7 email, DHS Deputy Under Secretary for Management Randolph D. Alles sent guidance to TSA officials, urging them to wear homemade cloth face coverings and maintain social distancing. But the N95s, which block 95% of particles that can transmit the virus, were in notoriously short supply and should be “reserved” for health care workers.

“The CDC has given us very good information about how to make masks that are suitable, so that we can continue to reserve medical masks and PPE for healthcare workers battling the COVID-19 pandemic,” Alles wrote.

But two days later, on April 9, Cliff Van Leuven, TSA’s federal security director in Minnesota, followed up and asked why he had been sent thousands of masks despite that guidance.

“I just received 9,000 N-95 masks that I have very little to no need for,” he said in the email, which was first reported by Government Executive. “We’ve made N95s available to our staff and, of the officers who wear masks, they overwhelmingly prefer the surgical masks we just received after a couple months on back order.”

Minnesota Gov. Tim Walz had publicly asked that anyone who had PPE donate their surplus to the state’s Department of Health, Van Leuven said in the email to senior TSA staff.

“I’d like to donate the bulk of our current stock of N-95s in support of that need and keep a small supply on hand,” he wrote, adding the Minneapolis-St. Paul International Airport had screened fewer than 1,500 people the previous day, about a third of which were airport staff.

Van Leuven declined to comment, referring questions to a TSA spokesperson.

Later that day, Kielkopf forwarded the concerns to TSA attorneys in other field offices, trying to get some attention to the stockpile he felt would be better used at hospitals.

“I am sharing with you some issues we are having with n95 masks in Minnesota,” he wrote. “And the tension between our increasing supply of n95 masks at our TSA airport locations and the dire need for them in the medical community.”

Weeks went by, and finally, on May 1, Kielkopf wrote: “I have been very disappointed in our position to keep tens of thousands of n95 masks while healthcare workers who have a medical requirement for the masks — because of their contact with infected people — still go without.”

DHS did not respond to ProPublica’s questions about why it transferred N95 masks to TSA despite a top official saying they should be reserved for healthcare workers.

“So now the TSA position is that we desperately need these masks for the protection of our people,” Kielkopf said. “At the same time, most of our people aren’t even working. It’s a complete 180 that doesn’t make any sense.”

Do you have access to information about federal contracts that should be public? Email david.mcswane@propublica.org. Here’s how to send tips and documents to ProPublica securely.

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by Joshua Kaplan and Benjamin Hardy

On April 17 in Toledo, Ohio, a 19-year-old black man was arrested for violating the state stay-at-home order. In court filings, police say he took a bus from Detroit to Toledo “without a valid reason.” Six young black men were arrested in Toledo last Saturday while hanging out on a front lawn; police allege they were “seen standing within 6 feet of each other.” In Cincinnati, a black man was charged with violating stay-at-home orders after he was shot in the ankle on April 7; according to a police affidavit, he was talking to a friend in the street when he was shot and was “clearly not engaged in essential activities.”

Ohio’s health director, Dr. Amy Acton, issued the state’s stay-at-home order on March 22, prohibiting people from leaving their home except for essential activities and requiring them to maintain social distancing “at all times.” A violation of the order is a misdemeanor, punishable by up to 90 days in jail and a $750 fine. Since the order, hundreds of people have been charged with violations across Ohio.

The state has also seen some of the most prominent protests against state stay-at-home orders, as large crowds gather on the statehouse steps to flout the directives. But the protesters, most of them white, have not faced arrest. Rather, in three large Ohio jurisdictions ProPublica examined, charges of violating the order appear to have fallen disproportionately on black people.

ProPublica analyzed court records for the city of Toledo and for the counties that include Columbus and Cincinnati, three of the most populous jurisdictions in Ohio. In all of them, ProPublica found, black people were at least four times as likely to be charged with violating the stay-at-home order as white people.

As states across the country attempt to curb the spread of COVID-19, stay-at-home orders have proven instrumental in the fight against the novel coronavirus; experts credit aggressive restrictions with flattening the curve in the nation’s hotbeds. Many states’ orders carry criminal penalties for violations of the stay-at-home mandates. But as the weather warms up and people spend more time outside, defense lawyers and criminal justice reform advocates fear that black communities long subjected to overly aggressive policing will face similarly aggressive enforcement of stay-at-home mandates.

In Ohio, ProPublica found, the disparities are already pronounced.

As of Thursday night in Hamilton County, which is 27% black and home to Cincinnati, there were 107 charges for violating the order; 61% of defendants are black. The majority of arrests came from towns surrounding Cincinnati, which is 43% black. Of the 29 people charged by the city’s Police Department, 79% were black, according to data provided to ProPublica by the Hamilton County Public Defender.

In Toledo, where black people make up 27% of the population, 18 of the 23 people charged thus far were black.

Lt. Kellie Lenhardt, a spokeswoman for the Toledo Police Department, said that in enforcing the stay-at-home order, the department’s goal is not to arrest people and that officers are primarily responding to calls from people complaining about violations of the order. She told ProPublica that if the police arrested someone, the officers believed they had probable cause, and that while biased policing would be “wrong,” it would also be wrong to arrest more white people simply “to balance the numbers.”

In Franklin County, which is 23.5% black, 129 people were arrested between the beginning of the stay-at-home order and May 4; 57% of the people arrested were black.

In Cleveland, which is 50% black and is the state’s second-largest city, the Municipal Court’s public records do not include race data. The court and the Cleveland Police Department were unable to readily provide demographic information about arrests to ProPublica, though on Friday, the police said they have issued eight charges so far.

In the three jurisdictions, about half of those charged with violating the order were also charged with other offenses, such as drug possession and disorderly conduct. The rest were charged only with violating the order; among that group, the percentage of defendants who were black was even higher.

Franklin Country is home to Columbus, where enforcement of the stay-at-home order has made national headlines for a very different reason. Columbus is the state capital and Ohio’s largest city with a population of almost 900,000. In recent weeks, groups of mostly white protesters have campaigned against the stay-at-home order on the Statehouse steps and outside the health director’s home. Some protesters have come armed, and images have circulated of crowds of demonstrators huddled close, chanting, many without masks.

No protesters have been arrested for violating the stay-at-home order, a spokesperson for the Columbus mayor’s office told ProPublica. Thomas Hach, an organizer of a group called Free Ohio Now, said in an email that he was not aware of any arrests associated with protests in the entire state. The Columbus Division of Police did not respond to ProPublica’s request for comment.

Ohio legislators are contemplating reducing the criminal penalties for violating the order. On Wednesday, the state House passed legislation that would eliminate the possibility of jail time for stay-at-home violators. A first offense would result in a warning, and further violations would result in a small fine. The bill is pending in the state Senate.

Penalties for violating stay-at-home orders vary across the country. In many states, including California, Florida, Michigan and Washington, violations can land someone behind bars. In New York state, violations can only result in fines. In Baltimore, police told local media they had only charged two people with violations; police have reportedly relied on a recording played over the loudspeakers of squad cars: “Even if you aren’t showing symptoms, you could still have coronavirus and accidentally spread it to a relative or neighbor. Being home is being safe. We are all in this together.”

Enforcement has often resulted in controversy. In New York City, a viral video showed police pull out a Taser and punch a black man after they approached a group of people who weren’t wearing masks. Police say the man who was punched took a “fighting stance” when ordered to disperse. In Orlando, police arrested a homeless man walking a bicycle because he was not obeying curfew. In Hawaii, charges against a man accused of stealing a car battery, normally a misdemeanor punishable by up to 30 days in jail, were enhanced to a felony, which can result in 10 years in prison, because police and prosecutors said he was in violation of the state order.

The orders are generally broad, and decisions about which violations to treat as acceptable and which ones to penalize have largely been left to local police departments’ discretion.

Kristen Clarke, president of the Lawyers’ Committee for Civil Rights Under Law, a legal organization focused on racial justice, said such discretion has opened the door to police abuse, and she said the U.S. Department of Justice or state governments should issue detailed guidelines about when to make arrests. That discretion “is what’s given rise to these rogue practices,” she told ProPublica, “that are putting black communities and communities of color with a target on their backs.”

In jails and prisons around the country, inmates have fallen ill or died from COVID-19 as the virus spreads rapidly through the facilities. Many local governments have released some inmates from jail and ordered police to reduce arrests for minor crimes. But in Hamilton County, some people charged with failing to maintain social distancing have been kept in jail for at least one night, even without any other charges. Recently, two sheriff’s deputies who work in the jail tested positive for COVID-19. “The cops put their hands on them, they cram them in the car, they take them to the [jail], which has 800 to 1400 people, depending on the night,” said Sean Vicente, director of the Hamilton County Public Defender’s misdemeanor division. “It’s often so crowded everyone’s just sitting on the floor.”

Clarke said the enforcement push is sometimes undercutting the public health effort: “Protecting people’s health is in direct conflict with putting people in overcrowded jails and prisons that have been hotbeds for the virus.”

Court records show that the Cincinnati Police Department has adopted some surprising applications of the law.

Six people were charged with violations of the order after they were shot. Only one was charged with another crime as well, but police affidavits state that when they were shot, they were or likely were in violation of the order. One man was shot in the ankle while talking to a friend, according to court filings, and “was clearly not engaged in essential activities.” Another was arrested with the same explanation; police wrote that he had gone to the hospital with a gunshot wound. The Cincinnati Police Department did not respond to ProPublica’s requests for comment.

In Springfield Township, a small, mostly white Cincinnati suburb, nine people have been arrested for violating the order thus far. All of them are black.

Springfield Township Police Chief Robert Browder told ProPublica in an email that the department is “an internationally accredited law enforcement organization” and has “strict policies ... to ensure that our zero tolerance policy prohibiting bias-based profiling is adhered to.”

Browder said race had not played a role in his department’s enforcement of the order and that he was “appalled if that is the insinuation.”

Several of the black people arrested in Springfield Township were working for a company that sells books and magazine subscriptions door to door. One of the workers, Carl Brown, 50, said he and five colleagues were working in Springfield Township when two members of the team were arrested while going door to door. Police called the other sales people, and when they arrived at the scene, they too were arrested. Five of them, including Brown, were charged only with violating the stay-at-home order; the sixth sales person had an arrest warrant in another state, according to Browder, and police also charged her for giving them false identification.

Brown said one of the officers had left the group with a warning: They should never come back, and if they do, it’s “going to be worse.”

Browder denied that the officers made such a threat, and he said the police had received calls from residents about the sales people and their tactics and that the sales people had failed to register with the Police Department, as required for door-to-door solicitation.

Other violations in Hamilton County have been more egregious, but even in some of those cases, the law enforcement response has stirred controversy. On April 4, a man who had streamed a party on Facebook Live, saying, “We don’t give a fuck about this coronavirus,” was arrested in Cincinnati’s Over-the-Rhine neighborhood, the setting of a 2001 riot after police fatally shot an unarmed black man.

The man who streamed the party, Rashaan Davis, was charged with violating the stay-at-home order and inciting violence, and his bond was set at $350,000.

After Judge Alan Triggs said he would release Davis from jail pretrial because the offense charged was nonviolent, local media reported, prosecutors dropped the misdemeanor and said they would focus on the charge of inciting violence, a felony.

The Hamilton County prosecutor’s office declined to comment on Davis’ case.

In Toledo, there’s been public controversy around perceived differences in the application of the law. On April 21, debate at the Toledo City Council meeting centered around a food truck. Local politicians discussed recent arrests of young black people at house parties, some contrasting them with a large, white crowd standing close together in line outside a BBQ stand, undisturbed by police. Councilmember Gary Johnson told ProPublica he’s asked the police chief to investigate why no one was arrested at a party he’d heard about, where white people were congregating on docks. “I don’t know the circumstances of the arrests,” he said. But “if you feel you need to go into poor neighborhoods and African American neighborhoods, you better be going into white neighborhoods too. … You have to say we’re going to be heavy-handed with the stay-at-home order or we’re going to be light with it. It has to be one or the other.”

Toledo police enforcement has not been confined to partygoers. Armani Thomas, 20, is one of the six young men arrested for not social distancing on a lawn. He told ProPublica he was sitting there with nine friends “doing nothing” when the police pulled up. Two kids ran off, and the police made the rest stay, eventually arresting “all the dudes” and letting the girls go. He was taken to the county jail, where several inmates have tested positive, for booking and released after several hours. The men’s cases are pending.

“When police see black people gathered in public, I think there’s this looming belief that they must be doing something illegal,” RaShya Ghee, a criminal defense attorney and lecturer at the University of Toledo, told ProPublica. “They’re hanging out in a yard — something illegal must have happened. Or, something illegal is about to happen.”

Lenhardt, the police lieutenant, said the six men were arrested after police received 911 calls reporting “a group gathering and flashing guns.” None of the six men were arrested on gun charges. As for the 19-year-old charged for taking the bus without reason, she said police asked him on consecutive days to not loiter at a bus station.

With more than 70,000 Americans dead from the coronavirus, government officials have not figured out how to balance the threat of COVID-19 with the harms of over policing, Clarke said. “On the one hand, we want to beat back the pandemic. That’s critical. That’s the end goal,” she told ProPublica. “On the other hand, we’re seeing social distancing being used as a pretext to arrest the very communities that have been hit hardest by the virus.”

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It was just confirmed that I'll be teaching in Temple University's RA/QA MS program this spring. Specifically, I'll be teaching the ad-promo course.

If you or anyone you know is interested, please reach out to me for information. The course will be taught out of the Fort Washington campus, but online enrollment is permitted.

Here's the complete schedule of classes for the spring.

Supplies of the selective serotonin reuptake inhibitor, sertraline, are returning to stock after manufacturers reported “industry-wide” supply challenges, exacerbated by export bans and border closures implemented as a result of COVID-19. 

To read the whole article click on the headline

A manufacturer has announced plans to move production of hydroxychloroquine — currently being trialled as a COVID-19 treatment — to the UK from abroad to combat potential shortages.

To read the whole article click on the headline

March 23, 2020 – As the United States grapples with the COVID-19 outbreak and its ongoing fallout, there is another pressing issue that is crucial to the American public: ensuring safe and fair elections between now and Nov. 3. “The Coalition believes it is important for all Americans to be active in the political process […]

April 6, 2020 – The Coalition for Healthcare Communication last week endorsed an urgent request to Maryland Governor Larry Hogan (R) to veto HB 732, which would put in place the nation’s first tax on digital advertising. The request, sent March 31 by national media and advertising trade associations and members of The Advertising Coalition, […]

The European Medicines Agency has begun a rolling review of data on Gilead’s remdesivir, positioning it to cut the time it takes to decide whether to approve the drug in COVID-19 patients.

Inovio Pharmaceuticals’ stock has climbed higher and higher over the past month since it said it was working on a speedy COVID-19 vaccine.

After penning a deal with Eli Lilly last month with the aim to have an antibody in the clinic within four months, Canadian-based AbCellera has been given a financial boost by its government.

Moderna is finalizing the protocol for a phase 3 trial of its COVID-19 vaccine with a view to starting the study early in the summer. The establishment of the timeline, which follows FDA clearance to run a phase 2 trial, puts Moderna on track to win approval for its mRNA vaccine mRNA-1273 next year.

GlaxoSmithKline is hard at work with partner Sanofi in getting a vaccine tested for COVID-19, but this morning it said it was now also entering the race to treat patients already hit with the disease.

Fortress Biotech has licensed a treatment for KRAS-driven cancers from Columbia University. Sticking to its blueprint, Fortress has set up a new biotech, Oncogenuity, to advance the preclinical asset and work to generate more oligonucleotides from the underlying platform.

A new report out by Innova Market Insights has identified several new trends that are driving sports nutrition.

There is an âindisputable relation between vitamin D and the immune systemâ, says a new review that shows that avoiding vitamin D deficiency has clear benefits for immune health.

Recent research suggests that some brands may want to calm down their messaging.

The GMP Starter Kit aims to help guide brands through current Good Manufacturing Practices (cGMP) regulations and FDA compliance for nutritional and dietary supplement brands.

Marketing experts recommend that brands formulate a strategy to be as nimble as possible to deal with the as yet unknown changes to the supplement marketplace in the post pandemic world. A greater online capability is seen as one of key parts of that toolkit.