Posted by Michael Wonder on 16 Oct 2022
Battle over pregnancy drug highlights risks of FDA expediting drugs to market
16 October 2022 - The year's long effort to yank the drug's approval offers a case study of the agency's accelerated approval program, which green-lit Makena in 2011.
The FDA will make its case this week to do something it hasn’t in over a decade — order a drug it expedited to the market to be pulled.
