The US Food and Drug Administration should issue summaries immediately after advisory committee meetings and proactively explain the discordance when its final regulatory decisions differ from advice provided by the external experts, according to stakeholders.
Key Takeaways
-
FDA should be more proactive in its communications to clear up misperceptions about the role expert panels play.
-
The agency should issue meeting summaries immediately after adcomms and publicly explain why a regulatory decision diverges from panel advice, stakeholders said
Such measures could help build public confidence in the advisory committee process and the agency’s own decision-making, explained participants at a 13 June
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
Already a subscriber?