Internal US FDA Disagreements Feature In One-Quarter Of Novel Approvals
Executive Summary
A team led by Dalhousie University researchers examined 174 novel approvals from 2011-2015 and found 155 instances of disagreement, affecting 42 drugs.
You may also be interested in...
US FDA's Integrated Review Doc: Industry Says Don't Lose The Detail
Stakeholders, some worried about "groupthink," tell the US FDA they want the individual discipline comments on newly approved drugs to stay in action packages because of the valuable insights they provide.
Savaysa A-Fib Data Led To Conflicting FDA Views On Dose, Population
Reviewers debated whether to approve Daiichi’s oral anticoagulant only for atrial fibrillation patients with renal impairment or a higher-than-tested dose for those with normal renal function. Disagreements over how to handle renal subgroup efficacy findings also led to differences of opinion on the need for a REMS.
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.