FDA Changed Course On Zontivity Because Of Skepticism Of Subgroups At High Levels
Large, complex dataset supporting Merck’s vorapaxar NDA invited “slicing and dicing” of the data by the primary reviewers – and made weight-based restrictions a key issue at the late-cycle and advisory committee meetings. But unusual, late-in-the-game reviews by high level FDA officials led to a post-panel U-turn.
You may also be interested in...
Internal US FDA Disagreements Feature In One-Quarter Of Novel Approvals
A team led by Dalhousie University researchers examined 174 novel approvals from 2011-2015 and found 155 instances of disagreement, affecting 42 drugs.
A Cautious Guide To The Interpretation Of Clinical Trials From NEJM
Determining the success or failure of a randomized trial requires looking beyond the p-value for the primary endpoint, review articles in The New England Journal of Medicine urge.
Case Studies In FDA's Regulatory Interpretation Of Clinical Trials
For more than 15 years, the Pink Sheet's Drug Review Profile series has looked closely at FDA approval documents, providing a long view of the pitfalls and pitches presented in the NEJM series on interpreting clinical trial results.