Medical Device Legal News with Sam Bernstein: Episode 18
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Taking the Pulse, A Health Care and Life Sciences Podcast | Episode 104: Dr. Nicholas Vafai, Founder and President, Viro Research
DE Talk | Navigating COVID-19 Vaccine Mandates: Employer vs Employee Rights
Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
What device companies need to know ahead of an advisory panel meeting
On August 22, Moderna announced that FDA approved its supplemental Biologics License Application (“sBLA”) for a new formula of their COVID-19 vaccine, SPIKEVAX®, for individuals 12 years old and above. Emergency Use...more
The Food and Drug Administration (FDA) has recently undertaken a number of notable actions with respect to vaccines in response to the ongoing COVID-19 pandemic....more
In the past week, the FDA authorized Pfizer’s and Merck’s oral antivirals for the treatment of COVID-19. The Biden-Harris Administration released the Trucking Action Plan. The CDC endorsed ACIP recommendation of preference...more
The coronavirus keeps ripping through the country with a fourth, Delta-variant fueled surge that also is producing confounding, confused behaviors that only add to the pandemic’s considerable gloom. The pandemic, which...more
On Monday, the Food and Drug Administration gave permanent approval to Pfizer’s COVID-19 vaccine. Similar approval of the Moderna vaccine may be forthcoming, with eventual approval of the Johnson & Johnson one-shot...more
The U.S. Food and Drug Administration's ("FDA") approval of the Pfizer vaccine under a new brand name, Comirnaty, created a cascade of legal and regulatory issues for prescribers, pharmacies, and other vaccine administrators....more
Over the past year and a half, employers have become all too familiar with various public health agencies and their regulations, recommendations, and preventative measures. For the past several months, a big question for...more
On August 23, 2021, the U.S. Food and Drug Administration (FDA) fully approved the Pfizer vaccine for those 16 and older - the first full approval of the three COVID-19 vaccines available in the U.S. The Moderna and Johnson &...more
Yesterday, the U.S. Food and Drug Administration (FDA) granted “full approval” to the Pfizer-BioNTech COVID-19 vaccine for individuals 16 years of age and older. In other words, the Pfizer-BioNTech vaccine (which will now be...more
On August 23, 2021, the U.S. Food and Drug Administration (FDA) granted full approval to Pfizer’s COVID-19 vaccine. Moderna’s expedited application for full approval is still pending, and Johnson & Johnson plans to submit its...more
Seyfarth Synopsis: Today the FDA approved Comirnaty (COVID-19 Vaccine, mRNA), previously known as Pfizer-BioNTech COVID-19 Vaccine, to prevent COVID-19 disease in individuals 16 and older. This could be big news for those on...more
Due to the recent increase in COVID-19 cases, California officials are recommending that private employers require their employees to be vaccinated against COVID-19 or face regular testing. In an article in the Sacramento...more
In Washington: Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky urged parents to vaccinate adolescents and teenagers against the coronavirus Friday, adding that COVID-19 can be severe for this age...more
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In Tuesday's Report: FDA revokes...more
As we ring in the new year, we look back at the top U.S. biosimilar market developments of 2020. Here are some of our highlights, in no particular order...more
In Washington: Top Senate Republicans indicated on Thursday that Congress is increasingly likely to need a brief stopgap government funding bill lasting several days to clinch a spending and coronavirus relief deal. Friday...more
In Washington: The “four corners”— House Speaker Nancy Pelosi (D-CA), House Minority Leader Kevin McCarthy (R-CA), Senate Minority Leader Chuck Schumer (D-NY), Senate Majority Leader Mitch McConnell (R-KY)—are reportedly...more
On December 11, 2020, FDA issued the first emergency use authorization (“EUA”) for a vaccine to prevent COVID-19. The vaccine, developed by Pfizer-BioNTech, is authorized for those 16 years of age and older....more
In Washington: The Senate passed a one-week stopgap bill on Friday, hours ahead of a government shutdown deadline. The bill passed on a voice vote and moved the funding deadline to December 18. The continuing resolution...more
Since COVID-19 strong-armed its way to the forefront of the US media in March 2020, we’ve seen hundreds, even thousands of news stories, opinion pieces, and agency reports on related topics ranging from its impact on schools...more
The FDA’s Vaccines and Related Biological Products Advisory Committee voted 17 to 4 with 1 abstention and 1 no vote that based upon the available scientific evidence, the benefits of the Pfizer and BioNTech’s COVID-19 vaccine...more
In Washington: President-elect Joe Biden picked California Attorney General Xavier Becerra to be his health secretary. Becerra was a defender of the Affordable Care Act. Separately, Biden picked a Harvard infectious...more
In Washington: Congress continues to debate a new coronavirus relief package, possibly as part of a government spending bill due December 11. Here are the latest developments...more
Tuesday, 24 November 2020 - U.S. President-elect Joe Biden has pledged to expand the role of the federal government in response to the COVID-19 public health emergency, build on the Affordable Care Act, and continue drug...more
The eagerly anticipated news of coronavirus (COVID-19) vaccine candidates last week has been welcomed by the scientific community across the globe. For employers, the news has prompted consideration of the potential...more