News & Analysis as of

Vaccinations Regulatory Oversight

Cozen O'Connor

HHS Advocates Mandated Placebo-Controlled Trials for New Vaccines: Implications for Clinical and Regulatory Practice

Cozen O'Connor on

The Department of Health and Human Services (“HHS”) recently proposed a policy that would require all new vaccines to undergo placebo-controlled clinical trials prior to FDA approval. The proposal, while controversial, is...more

Bradley Arant Boult Cummings LLP

Happy Thanksgiving and the Many Things for Which We Are Thankful – 2021 Edition

Many of us are understandably anxious to put another tumultuous year of the pandemic behind us. But before we sit down at the table to fill our plates and bellies to overflowing to celebrate the holiday, we can all find some...more

Cozen O'Connor

Council Looks to Incentivize Vaccines, New Police Oversight Board Passes Council

Cozen O'Connor on

CITY HALL - Counsel Looks to Incentivize Vaccines - Members of City Council will review two proposals to incentivize vaccines citywide. The first proposal would give residents a $50 credit to use on Philadelphia Gas...more

McDermott Will & Schulte

[Webinar] 2021 +Dx Diagnostics Forum - April 6th, 12:00 pm - 3:30 pm EST

Celebrating its sixth program, McDermott+Consulting’s +Dx Diagnostics Forum is the premier annual program for the laboratory diagnostics community. Gain insight into how the industry addresses regulatory and business...more

Bass, Berry & Sims PLC

American Rescue Plan Act of 2021: Healthcare Highlights

Bass, Berry & Sims PLC on

Yesterday, President Biden signed into law the American Rescue Plan Act of 2021 (Act), which narrowly passed the U.S. Senate (50 – 49) and House of Representatives (220 – 211) earlier this week. The Act provides for $1.9...more

Holland & Knight LLP

A Snapshot Look at COVID-19 Vaccine Distribution Logistics

Holland & Knight LLP on

In December 2020 when this blog series was planned, national attention had turned from developing a COVID-19 vaccine to distributing it. The expectation was that this blog would focus on the successes and logistical...more

American Conference Institute (ACI)

[Virtual Event] 36th Annual FDA Boot Camp - March 24th - 25th, 8:15 am - 1:45 pm EDT

ACI’s FDA Boot Camp returns in a completely interactive virtual format to help life sciences attorneys and executives to master the fundamentals of FDA Regulation... Gain essential working knowledge of core FDA concepts,...more

Hogan Lovells

Coronavirus: The Hill and the Headlines – COVID-19 D.C. Update – September 2020 #1

Hogan Lovells on

In Washington - White House Chief of Staff Mark Meadows on Tuesday said that there has been “real progress” in talks with congressional Democrats and Republicans on coronavirus relief legislation. ...more

Hogan Lovells

Coronavirus: The Hill and the Headlines – COVID-19 D.C. Update – May 2020 #12

Hogan Lovells on

In Washington: Sen. Debbie Stabenow (D-MI) and Senate Minority Leader Chuck Schumer (D-NY) will be launching a messaging campaign on “the cost of Republican inaction during the COVID-19 crisis.”  Schumer said President...more

McDermott Will & Schulte

[Webinar] Diagnostics, Antibody Testing and Vaccines: Global Outlook on Life Sciences COVID-19 Advances and Evolving Deal Trends -...

Across the US and EU, life sciences companies are pushing diagnostics, antibody testing, vaccines and other efforts forward to flatten the Coronavirus (COVID-19) curve. Our multidisciplinary cross-border life sciences team...more

Hogan Lovells

EMA publishes draft guideline on the quality of water for pharmaceutical use

Hogan Lovells on

The EMA has published a draft Guideline on the quality of water for pharmaceutical use. The draft is intended to provide guidance to the industry. It concerns the pharmaceutical use of different grades of water in the...more

Hogan Lovells

FDA Seizes Stem Cell Therapy—A First of Many?

Hogan Lovells on

On August 25, 2017, U.S. Marshals Service, at the request of FDA, seized five vials of ACAM20000—a smallpox vaccine containing live vaccinia virus (cow pox), which is reserved for people at high risk of contracting the...more

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