Human Drugs
Content/Process Guide for Pediatric Study Plans
FDA posts a final guidance on content and submission process for pediatric study plans.
Human Drugs
Janssen sNDA for Spravato OKd for Major Depression
FDA approves a Janssen Pharmaceutical supplemental NDA for Spravato (esketamine) nasal spray, taken with an oral antidepressant, to treat depressive s...
Federal Register
Drug User Fee Rates for FY 2021
Federal Register notice: FDA announces the rates for prescription drug user fees for fiscal year 2021.
Federal Register
Device User Fees for FY 2021
Federal Register notice: FDA announces the fee rates and payment procedures for medical device user fees for fiscal year 2021.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Medical Devices
Ethicon Breakthrough Status for Transbronchial Ablation
FDA grants Ethicon a breakthrough device designation for its transbronchial microwave ablation technology using robotic-assisted bronchoscopy.
Federal Register
Submission Data Elements for Imported Vet Devices
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
FDA Withdraws Watson Generic Oxycodone/Ibuprofen
Federal Register notice: FDA withdraws approval of a Watson Pharmaceutical ANDA for oxycodone hydrochloride and ibuprofen tablets, indicated for relie...
Human Drugs
Genentech Triple Combo OKd for Melanoma
FDA approves a Genentech supplemental BLA for its triple combination of Tecentriq (atezolizumab) plus Cotellic (cobimetinib) and Zelboraf (vemurafenib...
Federal Register
FDA Adds 4 APIs to Compounding List
Federal Register notice: FDA identifies four drug substances to be added to its list of bulk drug substances (active pharmaceutical ingredients) for w...
