[ Price : $8.95]
FDA issues a question-and-answer guidance on data integrity and compliance with drug CGMPs.[ Price : $8.95]
FDA issues a guidance explaining user fees and refunds for PMAs and some device BLAs as outlined in the MDUFA 4 agreement.[ Price : $8.95]
FDA cautions consumers that two HelloCig e-liquids illegally contain undeclared prescription drug active ingredients used to treat...[ Price : $8.95]
Three Fried Frank attorneys say the Justice Department must allow discovery on False Claims Act questions of materiality if the go...[ Price : $8.95]
TherapeuticsMD asks FDA to issue a product-specific bioequivalence guidance for its Imvexxy estradiol product.[ Price : $8.95]
FDA accepts an Intra-Cellular Therapies NDA for lumateperone, an investigational agent for treating schizophrenia.[ Price : $8.95]
FDA issues Mallinckrodt subsidiary SpecGx a complete response letter on its NDA for its investigational abuse-deterrent, immediate...[ Price : $8.95]
Three stakeholders generally praise FDA for its draft guidance on developing human gene therapy products to treat hemophilia.