Federal Register notice: FDA creates a public docket to collect comments related to pediatric post-marketing pharmacovigilance and drug utilization re...
FDA says its updated analysis supports continuing to make ketoconazole 200 mg tablets available on the market for its limited indications and with add...
FDA denies a United Therapeutics petition asking it to establish specific requirements for approving an ANDA for generic Tyvaso, without saying whethe...
FDA warns a Netherlands firm it is marketing a medical device in the U.S. without agency approval or clearance.
FDA places a clinical hold on two Cellectis Phase 1 studies involving cell therapy UCART123 in acute myeloid leukemia and in blastic plasmacytoid dend...
FDA warns Steiner Biotechnology about violations in its role as a sponsor-investigator of medical device clinical trials.
FDA warns Entellus Medical about violations in its work as sponsor of a medical device clinical study.
FDA releases its latest batch of Warning Letters that includes MB Industria Cirurgica, QLRAD Netherlands, Steiner Biotechnology and SyncThink.