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FDA posts a final guidance entitled E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post...[ Price : $8.95]
FDA accepts for review a Protalix BioTherapeutics and Chiesi BLA resubmission for PRX102 (pegunigalsidase alfa) for treating adult...[ Price : $8.95]
Federal Register notice: FDA makes available a revised draft guidance entitled ANDAs: Pre-Submission Facility Correspondence Relat...[ Price : $8.95]
FDA posts a draft guidance entitled ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions....[ Price : $8.95]
FDA adds Getinge Maquet/Datascope Intra-Aortic Balloon Pump devices to its device shortage list.[ Price : $8.95]
FDA releases a draft guidance entitled Statistical Approaches to Establishing Bioequivalence that is intended to provide recommend...[ Price : $8.95]
Federal Register notice: FDA announces the renewal of its Oncologic Drugs Advisory Committee for an additional two years beyond th...[ Price : $8.95]
A Boston federal judge sentences former co-owner of now-closed New England Compounding Center, Gregory Conigliaro, to one year in ...