That's why we are all gathered here this morning. Under the leadership of Attorney General Eric Holder, the U.S. Department of Justice has used a variety of tools to respond when law enforcement misconduct is uncovered. Those include everything from technical assistance provided by our Office of Justice Programs and our COPS Office to full-fledged enforcement actions by our Civil Rights Division and U.S. Attorney's Offices around the country, and everything in between.

The Department of Justice’s Civil Rights Division and the U.S. Attorney’s Office for the Southern District of Texas announced today that a federal grand jury in Houston returned a six count indictment charging Dante Phearse, 33, with calling in bomb threats to two Houston synagogues, a municipal courthouse and a private business.

A federal indictment returned under seal in June 2013 and unsealed today charges six foreign nationals, including a Ukrainian businessman and a government official in India, with participating in an alleged international racketeering conspiracy.

A former vice president of a Chesapeake, Va., government contracting company pleaded guilty today to conspiracy to pay bribes to public officials in exchange for favorable treatment in connection with U.S. government contract work.

Hope Cancer Institute, a cancer treatment facility in Kansas, and Dr. Raj Sadasivan, the owner of Hope Cancer Institute, have agreed to pay $2.9 million to resolve allegations that they violated the False Claims Act by submitting claims to Medicare, Medicaid and the Federal Employee Health Benefits Program for drugs and services that were not provided to beneficiaries.

The government has intervened in a False Claims Act lawsuit against Orbit Medical Inc. and Jake Kilgore alleging that Orbit Medical’s sales representatives boosted power wheelchair and accessory sales by altering and forging physician prescriptions and supporting documentation.

Macon Openshaw, 21, pleaded guilty in the U.S. District Court for the District of Utah today to a federal civil rights crime relating to a bias-motivated weapons discharge aimed at a local synagogue and to two unlawful gun possession charges.

Dante Phearse, 33, has entered a plea of guilty to calling in a bomb threat to Congregation Beth Israel, a synagogue in Houston.

A federal judge in California has permanently barred Michael I. Turner, of San Diego, from preparing federal tax returns for others, the Justice Department announced today.

A federal court in Chicago permanently barred Barbara L. Garrett from preparing tax returns for others or working for any business that prepares tax returns for others, the Justice Department announced today.

Baptist Health System Inc. (Baptist Health), the parent company for a network of affiliated hospitals and medical providers in the Jacksonville, Florida, area, has agreed to pay $2.5 million to settle allegations that its subsidiaries violated the False Claims Act by submitting claims to federal health care programs for medically unnecessary services and drugs.

The former executive director of the Legislature of the Virgin Islands was indicted today by a federal grand jury in the Virgin Islands for accepting bribes and engaging in extortion in the award of contracts with the Legislature.

The United States filed a complaint today to bar Laquanda O. Gilmore (aka Laquanda Garrott) and her company, L&g Associates LLC, from preparing federal tax returns for others, the Justice Department announced.

The Department of Justice will require ConAgra Foods Inc., Cargill Inc., CHS Inc. and Horizon Milling LLC to divest four competitively significant flour mills in order to proceed with the formation of Ardent Mills, a flour milling joint venture.

At the end of the day, if by working together we do change behavior at financial institutions, it will result in better returns for its investors, a safer environment for its depositors, better operations in the corporate boardrooms, and a better, more stable economy. Unfortunately, it may also result in less business for you.

The government has filed a complaint against CA Inc. (CA) for violations of the False Claims Act in connection with a General Services Administration (GSA) contract, the Justice Department announced today.

Acting Assistant Attorney General for the Justice Department’s Civil Rights Division Jocelyn Samuels, U.S. Attorney for the District of Montana Michael Cotter, Montana Attorney General Tim Fox, Missoula County Attorney Fred Van Valkenburg and Missoula County Commissioner Bill Carey will hold a press conference TOMORROW, TUESDAY, JUNE 10, 2014 at 1:00 p.m. EDT (11:00 a.m. MDT), to announce negotiated agreements regarding the handling of sexual assault cases

Acting Assistant Attorney General for the Justice Department’s Civil Rights Division Jocelyn Samuels and U.S. Attorney for the District of Montana Michael Cotter will hold a press call TOMORROW, TUESDAY, JUNE 10, 2014 at 1:45 p.m. EDT (11:45 a.m. MDT), for reporters who are unable to attend in person the 1:00 p.m. EDT (11:00 a.m. MDT), press conference announcing negotiated agreements regarding the handling of sexual assault cases

The Justice Department, Department of Housing and Urban Development (HUD), and the Consumer Financial Protection Bureau (CFPB), along with 49 state attorneys general and the District of Columbia’s attorney general have reached a $968 million agreement with SunTrust Mortgage Inc. (SunTrust) to address mortgage origination, servicing, and foreclosure abuses

Dante Phearse, 33, was sentenced today by U.S. District Judge Kenneth M. Hoyt to serve 33 months in prison for calling in a bomb threat to Congregation Beth Israel, a synagogue in Houston

Jaime Viteri, a Chicago businessman, pleaded guilty to two counts of willfully failing to file federal individual income tax returns today, announced the Justice Department and the Internal Revenue Service (IRS).

The Justice Department announced today that it reached a settlement with the city of Hubbard, Oregon, resolving an investigation of the city under Title I of the Americans with Disabilities Act (ADA). The investigation found that the city’s online employment application asked questions about disabilities in violation of the ADA. The ADA does not permit employers to inquire whether an applicant is an individual with a disability or as to the nature of such disability before making a conditional offer of employment. However, the ADA permits federal contractors subject to affirmative action requirements under Section 503 of the Rehabilitation Act of 1973 to invite an applicant voluntarily to self-identify as an individual with a disability, consistent with certain requirements. Last month, the department reached a similar settlement agreement with Florida State University

Macon Openshaw, 22, was sentenced today by U.S. District Court Judge Tena Campbell for the District of Utah to serve 60 months in prison for a bias-motivated attack at a local synagogue and for two unlawful gun possession charges

The United States filed a complaint today to bar Victor M. Crown, individually and through his businesses Crown and Franklin Accounting and Refunds, Crown-Franklin Accounting Inc., Accurate Accounting PV, and Lourdes Theodossis Estate, from promoting two alleged tax fraud schemes and from preparing federal tax returns for others, the Justice Department announced

Following his recent visit to Chicago where he participated in a roundtable discussion with Mayor Emanuel on recent reductions in youth violence, Attorney General Eric Holder today announced plans to send seven additional Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), agents to the field division office in Chicago

An Illinois man, who previously pleaded guilty to trafficking in counterfeit goods and introducing counterfeit drugs into interstate commerce in violation of the Food, Drug and Cosmetic Act, was sentenced today to serve 41 months in prison

The Justice Department announced today that it has filed a complaint against Midwest Neurosurgeons L.L.C. and its owner, Dr. Sanjay Fonn, M.D., and DS Medical L.L.C. and its owner, Deborah Seeger, for allegedly violating the Medicare Anti-Kickback Statute and the False Claims Act by conspiring to solicit and receive commissions from medical device manufacturers related to the purchase of spinal implants and supplies used during spinal fusion surgeries performed by Dr. Fonn

We recognize the Committee’s interest in this matter. We share that interest and are conducting a thorough and complete investigation and analysis of the allegations of targeting by the IRS. While I know you are frustrated by the fact that I cannot at this time disclose any specifics about the investigation, I do pledge to you that when our investigation is completed, we will provide Congress with detailed information about the facts we uncovered and the conclusions we reached in this matter

Tyree Davis Sr., 42, of Flossmoor, Illinois, pleaded guilty to two counts of obstruction of justice and two counts of filing false retaliatory liens against government officials, the Justice Department announced today

Brian Prokes, 28, a former office manager in the U.S. House of Representatives, pleaded guilty today for causing the House of Representatives to pay more than $19,000 in excess salary and unauthorized travel expenses, announced Assistant Attorney General Leslie R. Caldwell of the Justice Department’s Criminal Division

Timothy S. Miller, 58, a co-founder of a Chesapeake, Virginia, government contracting company, pleaded guilty today to providing illegal gratuities to two public officials working for the United States Navy Military Sealift Command

Adam Michael Webber, of Salt Lake County, Utah, was indicted on Friday by a federal grand jury in the District of Utah, the Justice Department announced. The indictment, which was made public today, charges Webber with one count of dealing in firearms without a license, one count of smuggling goods from the United States and six counts of filing false tax returns

The United States filed a complaint in federal court in Chicago to bar Laurie G. Helfer, aka Laurie G. Powell, individually and through her businesses Laurie’s Freelance & Tax Preparation Services and Tax Lady Laurie Inc., from preparing federal tax returns for others, the Justice Department announced today

Today, the United States won court approval of a settlement agreement to reform the ways in which the Portland Oregon Police Bureau (“PPB”) interacts with individuals with actual or perceived mental illness. The agreement was entered jointly by the United States and the city of Portland, Oregon, with the approval of the Albina Ministerial Alliance Coalition for Justice and Police Reform (“AMA Coalition”) and Portland Police Association (“PPA”). The agreement addresses constitutional claims in a civil action filed by the United States pursuant to the Violent Crime Control and Law Enforcement Act of 1994. In today’s order, the court approved the agreement with the requirement that the parties appear for periodic hearings to provide the court progress on implementation of the agreement.

Under a proposed settlement reached with the United States and the state of Indiana, the Atlantic Richfield Company and E.I. Du Pont de Nemours and Co. will pay for an estimated $26 million cleanup of lead and arsenic contamination in parts of a residential neighborhood in East Chicago, Indiana, announced the U.S. Department of Justice and the U.S. Environmental Protection Agency.

A federal jury returned guilty verdicts today against former Virginia Governor Robert F. McDonnell and former First Lady of Virginia Maureen G. McDonnell for participating in a scheme to violate federal public corruption laws.

Chairman Carper, Ranking Member Coburn and distinguished members of the committee, thank you for inviting me to speak with you today about the Department of Justice’s role in supporting state, local and tribal law enforcement agencies.

ZAO Hewlett-Packard A.O. (HP Russia), an international subsidiary of the California technology company Hewlett-Packard Company (HP Co.), pleaded guilty today to felony violations of the Foreign Corrupt Practices Act (FCPA) and was then sentenced for bribing Russian government officials to secure a large technology contract with the Office of the Prosecutor General of the Russian Federation.

By Ashley Henderson, PhD, CATO SMS Scientist 1.0 INTRODUCTION The COVID‑19 pandemic has added an unprecedented set of challenges to the conduct of clinical trials including quarantines, travel limitations, site closures, and interruptions in the supply chain of investigational products. In acknowledgement of these challenges, the Food and Drug Administration (FDA) recognizes that protocol modifications …

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Today's Daily Dose brings you news about FDA approval of Immunomedics' breast cancer drug; promising results from Kiniksa Pharma's prurigo nodularis trial; Mallinckrodt's regulatory catalyst; Myovant Sciences' phase III SPIRIT 2 study results and another disappointment in Parkinson's disease drug development space.

Today's Daily Dose brings you news about the acquisition of Portola by Alexion; encouraging results from TG Therapeutics' chronic lymphocytic leukemia trial; Akebia's INNO2VATE trial results; and Vapotherm's Q1 financial results.

Let's take a look at the biotech/pharma companies that are slated to report clinical trial results this quarter.

BASF recently announced the launch of Accelon™ absorption accelerating technology, developed as a breakthrough solution to the bioavailability challenge of today’s omega-3 supplements.

In the 8th edition of The Star Outstanding Business Awards (SOBA), ExcelVite has emerged as Gold winner for two award categories–Best Innovation and Best Global Market.

In this SupplySide West edition of the Healthy INSIDER podcast, Rachel Adams, managing editor, and Scott Steinford, founder and CEO of Trust Transparency Consulting, discuss the role of transparency in establishing trust with supplements consumers.  

From access to capital to dispute resolution.

Medical supplies and personal protective products are facing barriers worldwide

From : Communities>>Regulatory Open Forum
Hi Annie, I knew before that I wouldn't be able to attend to the webcast, so I did not register for it. But I am very curious on Dr. Akras insights. Is it possible to view a recording of it? Thanks, Britta ------------------------------ Britta Cyron Bochum Germany ------------------------------

From : Communities>>Regulatory Open Forum
Hi @Britta Cyron , Thanks for your question. Let me connect with m​y RAPS colleagues on this to get you an answer and then I will follow-up with you directly. Best, Annie ------------------------------ Annie O'Brien Community Manager Regulatory Affairs Professional Society regex@raps.org ------------------------------

From : Communities>>Regulatory Open Forum
Thank you for posting this here Annie as the webcast was excellent (as would be expected from Dr. Akra haha) - but really it was great to have this publicly available as there was nice information about the EU MDR conveyed. ------------------------------ Richard Vincins RAC Vice President Global Regulatory Affairs ------------------------------