BioCentury
ARTICLE | Regulation

Better decisions post-Avandia

How FDA aims to resolve future drug safety questions faster than Avandia

September 9, 2013 7:00 AM UTC

Three doctors who sit on FDA's Endocrinologic and Metabolic Drugs Advisory Committee have asked the agency to ease cardiovascular requirements for diabetes drugs now that it is known that Avandia rosiglitazone from GlaxoSmithKline plc did not pose the CV risk that meta-analysis had suggested it might.

The agency said it is "premature" to discuss its stance on the requirements for CV testing of diabetes drugs. But there are at least two initiatives under way that could help FDA more swiftly address safety questions that arise postmarket...