BioCentury
ARTICLE | Politics & Policy

FDA planning orphan workshops, pharmacology panel

September 24, 2013 12:53 AM UTC

FDA will hold public workshops on Jan. 6-8 to discuss development of drugs and devices to treat rare diseases. Topics for discussion include the use of surrogate endpoints and accelerated approval, as well as incentives to encourage the development of new therapies for rare pediatric diseases. The workshops are being held as part of FDA's commitments under PDUFA V (see BioCentury, July 2). ...