AUDIO-FDA staff feel the heat on drug approvals
FDA reviewers are under more and more pressure on drug approvals — from Congress, the media, families…
The spotlight doesn’t mean the agency has changed its standards, FDA Chief Medical Officer Janet Woodcock told the Reuters Health Summit.
But staff are worried they might be held individually accountable for any post-approval safety problems, and that means they’re looking ever more closely at the safety of new drugs before approving them. – By Sam Cage