1. Pink Sheet

Woodcock, Marks Recusals From COVID-19 Product Reviews 'Protect FDA's Reputation'

 
• By Brenda Sandburg

FDA experts say there is deep bench in CDER and CBER to tackle review questions while directors Janet Woodcock and Peter Marks help lead Operation Warp Speed; regulatory community is 'reassured' they will oversee advancement of COVID-19 therapeutics and vaccines.

wooden figures of people. rivals in business stand on the scales. competition. trial. conflict. victory and defeat. bad and good worker. concept of success and power
Top FDA officials recuse themsleves from COVID-19 product review decisions

Companies developing COVID-19 related products will no longer be able to turn to Janet Woodcock and Peter Marks – the respective directors of the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research – to get their input on review matters. But FDA experts say this will not have a significant impact on reviews and is the right move to avoid the appearance of impropriety.

The two were given leading roles in the Trump Administration's Operation Warp Speed, an initiative to facilitate the development, manufacturing and distribution of COVID-19 vaccines, therapeutics and diagnostics that was announced on 15 May. Marks is to oversee the development of vaccines and Woodcock is to oversee the work on therapeutics

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from US FDA

US FDA COVID-19 Booster Strategy May Not Be As Controversial As It Seems

 
• By Michael McCaughan

US FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea.

US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
• By Sarah Karlin-Smith

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

Califf In Conversation: ‘Decimated’ US FDA Teams Endanger Innovation

 
• By Barnaby Pickering

Pink Sheet sister publication In Vivo spoke to the former FDA commissioner about the recent layoffs and their impact on vaccine and other product development.

US FDA Vaccine Framework Coming In Weeks, But Details Vague

 
• By Sarah Karlin-Smith

New CBER Director Prasad will "unleash a massive" framework on vaccines, FDA Commissioner Marty Makary said 15 May, raising questions about the impact on products nearing approval.

More from Agency Leadership