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FDA requires a new warning and updates on clozapine products and related constipation risks, which can progress to serious bowel c...[ Price : $8.95]
Federal Register notice: FDA withdraws approval of a new animal drug application and two abbreviated new animal drug applications ...[ Price : $8.95]
Federal Register notice: FDA extends until 3/19 the comment period for its draft guidance on Demonstrating Substantial Evidence of...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Hematologic Malignancies: Regulatory Considerations for Use...[ Price : $8.95]
FDA seeks comments on two proposed studies entitled Endorser Status and Explicitness of Payment in Direct-to-Consumer Promotion.[ Price : $8.95]
FDA accepts for review a Corium 505(b)(2) NDA for Adlarity (donepezil transdermal system) for treating Alzheimers-type dementia.[ Price : $8.95]
FDA clears a GT Medical Technologies 510(k) for GammaTile Therapy expanded use in surgically targeted radiation therapy in patient...[ Price : $8.95]
FDA approves Mercks Dificid (fidaxomicin) oral suspension and tablets for expanded use treating Clostridium difficile infections ...