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CBER Director on COVID-19 and Vaccine Development

July 10, 2020

On July 8, the Alliance for a Stronger FDA was pleased to host a webinar with Peter Marks, MD, PhD, Director of FDA’s Center for Biologics Evaluation and Research. He joined the FDA in 2012 as CBER’s Deputy Director before becoming Director in 2016. … READ MORE …

Advocacy at a Glance

July 10, 2020

Top-Line: The House Appropriations Committee approved an FY 21 Ag/FDA funding bill with an increase of $41 million for FDA. CBER Director Dr. Peter Marks addressed Alliance members and the media on July 8 on vaccine development. There were nearly 100 participants and his remarks were widely covered by the media. This week’s Analysis and Commentary summarizes his remarks. The next Alliance webinar — with former FDA Chiefs of Staff — is on July 23. … READ MORE …

FDA Is Its People … and They Need Our Support (Redux)

June 26, 2020

Steven is away this week and suggested we reprint an edited version of one of his earlier columns on the FDA budget. … READ MORE …

Advocacy at a Glance

June 26, 2020

Top-Line: CBER Director Peter Marks, MD will address the Alliance on July 8. The Friday Update will not be published on July 3 in observance of Independence Day. The House plans to markup all of their appropriations bills beginning on July 6, while appropriations bills remain stalled in the Senate. FDA announced it will roll out the blueprint for the New Era of Smarter Food Safety in the coming weeks. This week’s Analysis and Commentary discusses some of FDA’s responsibilities and the budget it requires to perform its critical public health mission. … READ MORE …

How Well Is This Year’s Appropriation Process Working?

June 19, 2020

Q: Will the current set of House and Senate mark-ups be completed before August, setting up September enactment of FY 21 funding bills? … READ MORE …

Advocacy at a Glance

June 19, 2020

Top-Line: CBER Director Peter Marks, MD will be addressing the Alliance on July 8. The House and Senate still plan appropriations mark-ups, but the Senate faces new delays and the House won’t be starting until after the July 4th recess. FDA continues to publish guidance to aid sponsors whose clinical trials are at risk because of the pandemic. This week’s Analysis and Commentary returns to the Q&A format and addresses FDA’s situation within the current appropriations process. … READ MORE …

“I Believe in FDA Exceptionalism and You Should Too”

June 12, 2020

In a town full of special interests, it takes a certain moxie to claim that you represent needs that are uniquely important. … READ MORE …

Advocacy at a Glance

June 12, 2020

Top-Line: House and Senate schedules for Appropriations mark-ups have been set, but not specific dates or bills. The earliest Senate mark-up would be the week of June 22 and the House would be after Fourth of July recess. … READ MORE …