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.
You may also be interested in...
All NMEs and original BLAs are expected to adhere to the team-based review approach by the end of the year, with expansion to other application types later.
Of the two main contenders to lead FDA, Josh Sharfstein is seen as much more likely to open up review decisions to public scrutiny, while Janet Woodcock might be a vote for the status quo and more deferential to industry concerns.
A team led by Dalhousie University researchers examined 174 novel approvals from 2011-2015 and found 155 instances of disagreement, affecting 42 drugs.