Reagan-Udall Annual Meeting: 4 Takeaways From US FDA Center Directors

US FDA's center directors chime in on topics such as antimicrobial drug development and public education at the 2019 Reagan-Udall annual meeting.  

(From left to right) Michael McCaughan with FDA Center directors Jeff Shuren, Susan Mayne, Janet Woodcock and Peter Marks at Reagan-Udall Foundation for FDA.
(From left to right) Prevision Policy's Michael McCaughan with FDA center directors Jeff Shuren, Susan Mayne, Janet Woodcock, and Peter Marks at Reagan-Udall Foundation for the FDA. • Source: Ferdous Al-Faruque

US Food and Drug Administration wonks flocked to the Reagan-Udall annual meeting on 2 May to see new acting commissioner Norman Sharpless give one of his first public addresses. But the agency's center directors also convened to share some perspectives during a more than hour-long panel discussion. Below are some of the key takeaways from their remarks.

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

More from Agency Leadership

US FDA’s Makary Floats Vague ‘Plausible Mechanism’ Approval Pathway For Rare Diseases

 

Ascertaining the novelty and benefits of Makary’s new drug approval idea – along with what it would take to implement it – requires more clarity on the types of studies he envisions being used to grant and confirm “plausible mechanism’ approvals.

US FDA Commissioner Makary Wants To Combine Adverse Event Reporting Systems

 

In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.

US FDA User Fee Collection Safe In Preliminary Trump 2026 Budget Plan

 
• By 

The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.

FDA Special Assistant Høeg’s Vaccine Concerns On Display At ACIP

 
• By 

Tracy Beth Høeg, who is reportedly re-examining Novavax’s COVID vaccine application, is the FDA rep at the CDC panel’s first meeting under the Trump Administration. She raised concerns about routine use of Jynneos for adolescents at risk of mpox and questioned how Moderna assessed efficacy of its COVID vaccines.

More from Pink Sheet

Pulling Together: Global Regulators Discuss Convergence On Biosimilars

 
• By 

While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.

Chikungunya At US CDC: Bavarian Nordic’s Vimkunya Recommended, Valneva’s Ixchiq Adjusted

 

Bavarian Nordic's Vimkunya added the US CDC immunization committee's recommendation to its FDA approval, while Valneva's Ixchiq faces a precaution for use in people aged 65 and older.

US FDA Commissioner Makary Wants To Combine Adverse Event Reporting Systems

 

In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.