Another Reorg For US FDA Drug Office: Dispute Resolution Program Moves Out

In another sign of the increasing influence of generics within FDA, CDER Director Woodcock moves the formal dispute resolution program out of the Office of New Drugs.

FDA entrance sign 2016

In another sign of the the growing prominence of generics at the US FDA, the Center for Drug Evaluation and Research's formal dispute resolution program is moving out of the Office of New Drugs.

Most of the appeals now reviewed involve generics, Center for Drug Evaluation and Research Director Janet Woodcock said in the...

More from US FDA

Real-Time Release Of CRLs Is US FDA’s Goal, Agency Leaders Affirm

 

The US FDA says its release of complete response letters for products subsequently approved by the agency is just a first step toward releasing rejection letters when they are issued, assuming legal issues can be resolved.

Base Benefit-Risk Decisions On Data, Not Opinion And Passion, CDER’s Tidmarsh Says

 
• By 

New US FDA drugs center director George Tidmarsh’s data-centric comments at a Reagan-Udall Foundation meeting on unapproved fluoride products could suggest patients’ and caregivers’ experiences will carry less weight in benefit-risk decisions under his leadership.

Pink Sheet Podcast: FDA’s New Top Drug Regulator, Sarepta’s Options After Elevidys Stand-Off

Pink Sheet reporter and editors discuss the potential impact George Tidmarsh could have as director of the US FDA Center for Drug Evaluation and Research and the issues threatening the future of Sarepta’s gene therapy Elevidys.

US FDA’s Biologics Center Departures Grew Before More Than 100 RIFs Exited

 

The Center for Biologics Evaluation and Research saw departures far outnumber new hires in the second and third quarters of FY 2025, before more than 100 people left July 14 after the reduction-in-force was finalized.

More from Agency Leadership

US FDA’s Biologics Center Departures Grew Before More Than 100 RIFs Exited

 

The Center for Biologics Evaluation and Research saw departures far outnumber new hires in the second and third quarters of FY 2025, before more than 100 people left July 14 after the reduction-in-force was finalized.

US FDA Cancer Reviewers Heading For The Exits, Potentially Impacting Review Timelines

 

US FDA's cancer drugs division is feeling the effect of drug reviewer departures, despite efforts to keep them at the agency.

Quotable: Top Experts On Policy Hot Topics

 

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.