ARTICLE | Regulation

FDA's selective disclosure

December 18, 2000 8:00 AM UTC

WASHINGTON - When FDA posted its review of Maxim Pharmaceuticals Inc.'s Maxamine on the Internet on Tuesday, it provided the first public indication that the agency would express serious concerns about the company's NDA at an Oncologic Drugs Advisory Committee (ODAC) meeting the following day.

FDA's analysis sent MAXM shares into a tailspin; Tuesday's 44 percent sell-off was the most dramatic example of the impact of FDA's policy, initiated in January, of releasing briefing materials 24 hours in advance of advisory committee meetings (see Cover Story). ...