Federal Register notice: FDA announces the availability of a draft guidance entitled The Deemed to be a License Provision of the BPCI Act: Questions a...
FDA issues a question-and-answer guidance on data integrity and compliance with drug CGMPs.
FDA issues a guidance explaining user fees and refunds for PMAs and some device BLAs as outlined in the MDUFA 4 agreement.
FDA cautions consumers that two HelloCig e-liquids illegally contain undeclared prescription drug active ingredients used to treat erectile dysfunctio...
Three Fried Frank attorneys say the Justice Department must allow discovery on False Claims Act questions of materiality if the government wants the f...
TherapeuticsMD asks FDA to issue a product-specific bioequivalence guidance for its Imvexxy estradiol product.
FDA accepts an Intra-Cellular Therapies NDA for lumateperone, an investigational agent for treating schizophrenia.
FDA issues Mallinckrodt subsidiary SpecGx a complete response letter on its NDA for its investigational abuse-deterrent, immediate-release reformulati...