FDA issues a guidance to help sponsors develop drugs to treat patients with BCG-unresponsive nonmuscle invasive bladder cancer.
FDA approves an Endoceutics NDA for Intrarosa (prasterone) to treat women experiencing moderate to severe pain during sexual intercourse.
FDA releases a guidance on Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments, a revision that answers co...
Microbiology Devices Panel members recommend down-classification of cytomegalovirus viral load devices from Class 3 to Class 2.
GPhA asks FDA to evaluate all changes that made been made to the GDUFA program and eliminate any processes or mandates that arent necessary.
FDA says it has already approved Omthera Pharmaceuticals two petition requests seeking NCE exclusivity for its Epanova.
Four Hogan Lovells attorneys summarize new NIH policies that they say add pressure to the research compliance infrastructure of organizations conducti...
FDA says that HeartWare has recalled 105 of its ventricular assist devices manufactured in the last two years due to a design problem with the driveli...