The quality of the U.S. drug supply is the best it has ever been, according to CDER director of pharmaceutical quality Michael Kopcha, responding to a...
Federal Register notice: FDA makes available a final guidance entitled Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommenda...
Reps Rosa DeLauro (D-CT), Jan Schakowsky (D-IL), and Brian Fitzpatrick (R-PA) reintroduced the Medical Device Safety Act, a bill to increase access to...
FDA grants Sunovion Pharmaceuticals and PsychoGenics a breakthrough therapy designation for SEP-363856, a novel agent for treating people with schizop...
The Federal Trade Commission urges FDA to abandon its proposed naming convention for subsets of biologic products.
Federal Register notice: FDA makes available a draft guidance entitled Submitting Documents Using Real-World Data and Real-World Evidence to FDA for D...
Federal Register notice: FDA makes available a draft guidance entitled Postapproval Pregnancy Safety Studies that provides recommendations on how to d...
Federal Register notice: FDA makes available a draft guidance entitled Clinical Lactation Studies: Considerations for Study Design.