BioCentury
ARTICLE | Company News

Califf gives rationale for deferring Sarepta decision

November 5, 2016 12:00 AM UTC

FDA Commissioner Robert Califf chose not to make the approval decision for Exondys 51 eteplirsen from Sarepta Therapeutics Inc. (NASDAQ:SRPT) because he believes that decisions about products should be left to career employees, he said Friday.

"I had a decision to make which ended up being procedural because I didn't think a political appointee should be delving into individual product decisions," Califf said at a Friends of Cancer Research meeting. Califf deferred to the judgment of Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, in her decision to grant accelerated approval to the drug...

BCIQ Company Profiles

Sarepta Therapeutics Inc.