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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Three stakeholders generally praise FDA for its draft guidance on developing human gene therapy products to treat hemophilia.[ Price : $8.95]
FDAs Office of Regulatory Affairs steps up its Warning Letter issuance to pharmaceutical firms in fiscal year 2018, issuing 40% mo...[ Price : $8.95]
FDA classifies as Class 1 a GE Healthcare recall of its CareScape R860 Inspiratory Safety Guard, a breathing accessory designed fo...[ Price : $8.95]
FDA clears a DBM Corp. 510(k) for its Miracu PDO Suture Threads and its use on soft tissue approximation where absorbable sutures ...[ Price : $8.95]
FDA warns Chinas Zhejiang Huahai Pharmaceutical Co. about significant CGMP deviations in its production of active pharmaceutical i...