A citizen petition asks FDA to ban music in direct-to-consumer television, radio and internet streamed advertisements because it distracts the audienc...
FDA posts a final guidance on content and submission process for pediatric study plans.
FDA approves a Janssen Pharmaceutical supplemental NDA for Spravato (esketamine) nasal spray, taken with an oral antidepressant, to treat depressive s...
Federal Register proposed rule: FDA proposes to amend its regulations to require that certain data elements be submitted for veterinary devices that a...
Federal Register notice: FDA withdraws approval of a Watson Pharmaceutical ANDA for oxycodone hydrochloride and ibuprofen tablets, indicated for relie...
FDA approves a Genentech supplemental BLA for its triple combination of Tecentriq (atezolizumab) plus Cotellic (cobimetinib) and Zelboraf (vemurafenib...
Federal Register notice: FDA identifies four drug substances to be added to its list of bulk drug substances (active pharmaceutical ingredients) for w...