ARTICLE | Politics & Policy
FDA issues first breakthrough designation
November 15, 2012 12:46 AM UTC
FDA has "recently" issued the first breakthrough drug designation, Janet Woodcock, director of the Center for Drug Evaluation and Research, said on Wednesday. She said the agency cannot disclose the sponsor or drug candidate. The breakthrough designation, created by the FDA Safety and Innovation Act, commits FDA to collaborate with a sponsor to accelerate product testing and development (see BioCentury, July 2). ...