Federal Register notice: FDA announces the rates for prescription drug user fees for fiscal year 2021.
Federal Register notice: FDA announces the fee rates and payment procedures for medical device user fees for fiscal year 2021.
FDA grants Ethicon a breakthrough device designation for its transbronchial microwave ablation technology using robotic-assisted bronchoscopy.
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...