Drugmakers are slow to prove medicines that got a fast track to market really work wcbe.org - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from wcbe.org Daily Mail and Mail on Sunday newspapers.
An NPR investigation found stalled confirmatory trials and lax enforcement are plaguing the FDA's accelerated approval of drugs for urgent medical needs.
Stalled confirmatory trials and lax enforcement plague the Food and Drug Administration's accelerated approval pathway for pharmaceuticals that target urgent medical needs.
Stalled confirmatory trials and lax enforcement plague the Food and Drug Administration's accelerated approval pathway for pharmaceuticals that target urgent medical needs.
The Food and Drug Administration allows faster drug approvals based on preliminary study data if the drug fulfills an unmet medical need. But the speedy approval comes with a promise that the drugmaker does another clinical trial once the drug is on the market to prove it really works. If not, the FDA can rescind the approval. How are the companies doing and how well does the agency enforce that system? Pharmaceuticals correspondent Sydney Lupkin investigated the 30-year track record for accelerated approvals. Today, her findings on stalled trials and missing evidence.