1. Pink Sheet
  2. >>Regulatory Trackers
  3. >>US FDA Performance Tracker

Former FDA Commissioners Muse On Vaccine Surveillance – And The Next Operation Warp Speed

 
• By Brenda Sandburg

On the question of whether the US review of COVID vaccines is moving too slow compared to the UK, 'This is a lot of falderol,' Califf said.

Clockwise from top left: Meg Tirrell, Robert Califf, Mark McClellan, and Margaret Hamburg at the Milken Institute Future of Health Summit (screenshot)
Former FDA Commissioners discuss first COVID-19 vaccine and challenges ahead • Source: Screenshot from Milken Institute's Future of Health Summit

Immediately after the US Food and Drug Administration released its briefing document for the forthcoming advisory committee review of Pfizer Inc./BioNTech SE’s COVID-19 vaccine candidate, a panel of former FDA commissioners gave their positive take on the agency’s analysis.

Speaking at the Milken Institute’s 8 December Future of Health Summit, Mark McClellan, director of the Duke-Margolis Center for Health Policy at Duke University, said the 53-page document will help provide confidence in the vaccine. ”There’s nothing in there that I’ve seen or heard about on a quick look that would suggest big bumps in the road ahead at the advisory committee meeting,” McClellan said

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 Performance Tracker

Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
• By Bridget Silverman

Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.

Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
• By Bridget Silverman

The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.

AMR-Targeting Drug Secures EMA PRIME Designation

 
• By Neena Brizmohun

Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance.

US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
• By Bridget Silverman

Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.

More from Regulatory Trackers