Federal Register notice: FDA debars for five years Brenda K. Marmas from personally importing any drug into the U.S.
FDA tells Axsome Therapeutics that it will meet its inspection deadline on inspecting the companys contract manufacturing facility related to a 9/2021...
FDA publishes a draft guidance on the development of non-opioid analgesics for acute pain.
Eleven senators urge FDA to finalize its over-the-counter hearing aid rule quickly now that the public comment period has ended.
Three stakeholders comment on an FDA draft guidance on developing drugs to treat rhinosinusitis with nasal polyps.
AdvaMed says FDA should make changes to a discussion paper on 3D printing of medical devices at the point of care to explicitly include 3D printing of...
Gamida Cell initiates a rolling BLA submission for omidubicel, indicated for patients with blood cancers in need of stem cell transplant.
FDA approves safety-related labeling changes for Allergans anti-depressant drug Celexa.