April 27, 2020 – As the COVID-19 pandemic continues, the Food and Drug Administration (FDA) must balance safeguarding public health with the desire for timely product reviews. Staff members at the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research are working diligently to keep all of these balls in […]

May 4, 2020 – An important part of protecting the public health during the COVID-19 pandemic is making sure that the marketing of treatments or remedies that are not approved by the Food and Drug Administration (FDA) to treat the virus is stopped before consumers waste their money or potentially are harmed by these products. […]

Scientists work tirelessly to find a coronavirus vaccine. But there are some questions to answer: How soon a viable vaccine would be developed? Would billions of people worldwide be able to to get it?

"Today, 75 years later, we are forced to commemorate alone, but we are not alone!" Germany's President Frank-Walter Steinmeier says, celebrating international unity in the post-war era.

The tech giant announces it is extending its previous work-from-home plans for most of its staff and will begin reopening offices this summer.

The video has been viewed millions of times on YouTube via links that are replaced as quickly as the video-sharing service can remove them for violating its policy against "COVID-19 misinformation."

The Census Bureau says it plans to continue its relaunch of limited 2020 census operations on May 13, when the next round of workers is set to resume hand-delivering paper forms in rural communities.

And as summer nears, the question must be asked: Is it risky from a COVID-19 standpoint to go in a swimming pool?

A major health agency fears a humanitarian crisis. Migrant workers are returning home from the hard-hit Dominican Republic. Medical equipment is in short supply. And social distancing is improbable.

Marc Lipsitch, a professor of epidemiology at the Harvard School of Public Health, answers questions about access to testing for COVID-19, false-negative results and the challenges of mass testing.

By Monday at least 31 states will be open or partially open. This as President Trump pushed for the country to get back to work despite public health experts warning that it's too soon.

Call them victory anthems. Every time a patient with COVID-19 is well enough to be discharged, hospitals in New York and elsewhere play songs of celebration over the intercom. A doctor explains.

President Trump wants businesses to start reopening after the coronavirus forced shutdowns. Here's what the White House task force recommends for states.

Among those rallying against state shutdown orders are anti-vaccination activists. They see these protests as a way to form political alliances that promote their movement.

With social distancing, many people are speaking less and their voices sound raggedy. NPR's Scott Simon talks with speech pathologist Sandy Hirsch, about keeping the voice sounding as it should.

View our map and graphics to see where COVID-19 is hitting hardest in the U.S., which state outbreaks are growing the fastest and which are leveling off.

A map of confirmed COVID-19 cases and deaths around the world. The respiratory disease has spread rapidly across six continents and has killed thousands of people.

Following the European Parliament’s vote, the Council has now also agreed to the Brexit with its decision on the conclusion of the withdrawal agreement on behalf of the EU. The EU Parliamentarians sang off the UK members and celebrated that they never have to speak to Nigel Farage again. UK EU civil servants are clearing […]

The MDCG just published a joint implementation plan regarding the MDR. Here is my summary and analysis. It’s not a happy story. Not the IVDR This implementation plan is not about the IVDR, and the fact that it is not about the IVDR is information in itself. It means that the MDCG is not even […]

It has been some time since the MDCG guidance on cybersecurity for medical devices was released (MDCG 2019-16 December 2019), so everybody has probably had the opportunity to get used to the document by now. While the document is by no means ideal or even flawless (congratulations MDCG on a glaring spelling mistake in the […]

I have blogged before about the effects and possibilities of the Corrigendum of December 2019 for class I medical devices. I refer you to that blog for the background to this discussion, which covers the mechanics of timing. The draft corrigendum discussed in that blog was adopted as described.  The new guidance The MDCG has […]

What is this recommendation about? Obviously this recommendation is an attempt of the Commission to manage administative barriers to placing PPE (personal protective equipment) and medical devices on the market that would be needed in the struggle to get the current Covid-19 pandemic under control. In my view you can also see this as a […]

After a statement on a press conference today by Stefan De keersmaecker that had many people very excited quickly, the official announcement came later in the afternoon: Here is what I think about this development. Work on a proposal ongoing The Commission announced that ‘work on a proposal to postpone the date of application’. This tells […]

On Friday 3 April 2020 it finally happened: the Commission proposal for amendment of the MDR to defer the date of application with a year that everyone was waiting for and was in the works for some time was finally published. As I have heard from many directions immediately after the announcement of the proposal being […]

It’s always a risk to put out a theory about legislative oversight after a Sherlock Homes investigation that eliminates all other options as I did in my last blog about the MDR amendment proposal. Recent development seem to confirm that I was right in assuming that not touching the two dates of application of 26 […]

When it rains guidance, it pours. The MDCG just released Guidance on temporary extraordinary measures related to medical devices Notified Body audits during COVID-19 quarantine orders and travel restrictions. The guidance takes immediate effect and is valid for the whole period of duration of the pandemic COVID-19 as declared by the World Health Organisation. It […]

With the overwhelming vote in the Parliament in favor of the Commission proposal to amend the MDR it is politically basically a done deal now that the MDR will be amended. After the vote there were people that immediately stated that the amendment was formally approved – not so. We are looking at law making […]

If the worst thing that happens to me during this global pandemic is that I have to buy new pants, I will weep with gratitude.

Here is where masks are currently required, as well as proposals that would dramatically increase face-covering requirements.

In several states and in parts of California, black and Latino people are dying of COVID-19 at higher rates than their white and Asian counterparts.

Bill Oakley, a writer on "The Simpsons," admitted on Twitter that perhaps the animated TV show did forecast some of our troubling current events.

Los Angeles County, which continues to be the hardest hit area in California, announced 51 additional deaths linked to COVID-19 on Thursday.

Andy Serkis, who plays Gollum in the "Lord of the Rings" films, announced that he will livestream a reading of J.R.R. Tolkien's "The Hobbit" on Friday.

The Dodgers' Justin Turner and his wife Kourtney have delivered more than 500,000 meals to the needy since March. He'll be a free agent this winter.

The L.A. Pride parade, which would have marked its 50th year, joins the list of events canceled or postponed because of the coronavirus outbreak.

Newsom said earlier this week that bookstores, florists and others can reopen for curbside pickup Friday, unless barred by tougher local restrictions.

The coronavirus outbreak has forced the cancellation of myriad life events. Santa Clara County won't even let you celebrate in your car now.

As the economy has cratered, mortgage lenders tightened standards for people who are still interested in buying or refinancing a home.

Guns N' Roses frontman Axl Rose criticized Steven Mnuchin and Trump's coronavirus response, which irked the Treasury secretary and started a Twitter spat.

The U.N. triples its fundraising target for fighting the coronavirus, even as President Trump plans to freeze U.S. aid to its principal health agency.

For goodness sake, if you're going to hike, wear a mask.

California DMV will reopen 25 field offices after shutdown

Kings County Supervisor Doug Verboon said the outbreak at Central Valley Meat Company in Hanford accounts for nearly two-thirds of the coronavirus cases in the rural county, which has a total of 211 reported cases.

Orange County reported one additional coronavirus-linked fatality Thursday, bringing the region's total death toll to 66.

Until millions of Americans can be tested weekly for coronavirus, states will walk blindly into restarts. But NIH director has a plan to ramp up.

The good news: The state is far better prepared to meet this challenge than it was a decade ago. The bad news: It will need help from the feds, and a lot of it.

San Francisco will allow certain businesses to reopen beginning May 18 as it eases its stay-at-home orders. But officials warn that they will keep track to make coronavirus infections don't spike.

California Gov. Gavin Newsom says he doesn't see full stadiums of fans for sports happening amid the coronavirus outbreak until a vaccine is available.

A federal judge found that the uncertainty surrounding the COVID-19 pandemic was good cause for the delay.

Protesters of California's stay-at-home orders returned for another unsanctioned rally Thursday, telling law enforcement officers they are forgiven for arresting them last week.