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Federal Register notice: FDA corrects a 3/29 notice on the approval withdrawals of 30 ANDAs from multiple applicants due to Target...[ Price : $8.95]
FDA publishes a guidance explaining how CVM assesses human user safety in applicable animal drug applications.[ Price : $8.95]
FDA tells NDA and ANDA sponsors they must repeat clinical and bioanalytical studies conducted for their applications by Synapse La...[ Price : $8.95]
Six stakeholders express appreciation for and suggest improvements to an FDA draft guidance on using real-world evidence in non-in...[ Price : $8.95]
FDA publishes its report on an 11/2023 workshop on increasing clinical trial diversity.[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Facility Readiness: Goal Date Decisions Under GDUFA.[ Price : $8.95]
Federal Register notice: FDA announces a 7/17 educational conference (public meeting) entitled First Annual Animal Drug User Fee E...[ Price : $8.95]
A New York federal judge orders Stimwave founder and former CEO Laura Perryman to serve six years in jail for medical device healt...