The New Rules of Engagement: Inside the FDA’s Latest Formal Meeting Guidance
Over the years, the FDA has published several highly targeted series of iterations on formal PDUFA interactions, beginning with foundational frameworks under FDAMA in 2000, progressing through major updates in 2017 and 2018, and evolving into draft revisions in late 2023. The latest guidance released this week discusses important procedural and logistical preferences of the … Read more