US Food and Drug Administration Commissioner Robert Califf is raising concerns about how current advisory committee formats can influence meeting outcomes, and perhaps not for the better, as the agency undergoes a “stem to stern review” of the process for making key recommendations on drug approvals.
US FDA Advisory Committee Formats Can Spur Unhealthy Dynamics – Califf
FDA commissioner is thinking about how advisory panel interactions might improperly influence meeting outcomes as the agency undertakes a 'stem to stern' review of the process.
More from United States
• By
The US FDA has deemed certain in vitro bioequivalence studies conducted by CRO Raptim Research “not acceptable” and raised concerns over its in vivo study methods.
• By
Sector-specific tariffs, including on pharmaceuticals, could be announced as early as this week.
• By
Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.
• By
The former principal deputy commissioner said the “decapitation” of senior leadership will make resolving internal disputes more difficult, which will slow application reviews. Woodcock also called the FDA layoffs a slow-moving catastrophe.
More from North America
• By
The forced departure of CBER Director Peter Marks is a milestone event for the agency, as center directors now are likely to be treated as political positions subject to change with each new administration.
• By
Eli Lilly is seeking an injunction barring a weight loss clinic from dispensing modified versions of its GLP-1 products.
• By
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.