Drug Fix Special: Assessing US FDA Advisory Committee Reform Proposals

Pink Sheet reporters and editors and special guests from 3D Communications, a firm that helps sponsors prepare for advisory committee meetings, dig into the pros and cons of issues such as eliminating or reducing advisory committee votes (1:15), creating more time for committee discussion (10:25), committee member preparation (19:25), adding more temporary members (25:35), and in-person versus virtual meetings (30:45). They also discuss industry’s reaction to the reform campaign (39:10) and a roadmap for implementing changes (41:10). Read More On Advisory Committee Reform From The Pink Sheet US FDA Chief Scientist Wants To Make Advisory Committee Participation Easier: https://pink.pharmaintelligence.informa.com/PS148640/US-FDA-Chief-Scientist-Wants-To-Make-Advisory-Committee-Participation-Easier US FDA Center Directors Should Not Influence Adcomm Votes Or Overrule Scientific Staff, Coalition Says: https://pink.pharmaintelligence.informa.com/PS148566/US-FDA-Center-Directors-Should-Not-Influence-Adcomm-Votes-Or-Overrule-Scientific-Staff-Coalition-Says Expect More Temporary Members Voting In US FDA Advisory Committees: https://pink.pharmaintelligence.informa.com/PS148243/Expect-More-Temporary-Members-Voting-In-US-FDA-Advisory-Committees US FDA Adcomm Modernization Includes How Meetings Are Scheduled: https://pink.pharmaintelligence.informa.com/PS144678/US-FDA-Adcomm-Modernization-Includes-How-Meetings-Are-Scheduled Power To The (Adcomm) People: Members Believe Votes Should More Directly Affect US FDA Decisions: https://pink.pharmaintelligence.informa.com/PS144679/Power-To-The-Adcomm-People-Members-Believe-Votes-Should-More-Directly-Affect-US-FDA-Decisions US FDA Advisory Committees Could Get Revamp With A Focus On Science Over Emotion: https://pink.pharmaintelligence.informa.com/PS144485/US-FDA-Advisory-Committees-Could-Get-Revamp-With-A-Focus-On-Science-Over-Emotion US FDA Advisory Committees' Future: Drug-Agnostic Panels, More Debate Time: https://pink.pharmaintelligence.informa.com/PS147757/US-FDA-Advisory-Committees-Future-DrugAgnostic-Panels-More-Debate-Time US FDA Advisory Committee Formats Can Spur Unhealthy Dynamics – Califf: https://pink.pharmaintelligence.informa.com/PS148397/US-FDA-Advisory-Committee-Formats-Can-Spur-Unhealthy-Dynamics--Califf