BioCentury
ARTICLE | Regulation

Cardio panel not converted

December 17, 2007 8:00 AM UTC

FDA advisory committee meetings often focus on narrow technical or statistical issues specific to the compound up for review that can tip the balance between approval or rejection. The agenda for last week's meeting of the Cardiovascular and Renal Drugs Advisory Committee on two proposed therapies for atrial fibrillation went far beyond the usual boundaries to include a wide-ranging discussion about senior FDA officials' doubts about both the clinical value of these therapeutic interventions, as well as the utility of the endpoints used to measure their efficacy.

The heads of the agency's cardiovascular division did not win the support they apparently hoped to get...