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FDA puts a clinical hold on a Ceylad Oncology Phase 1b trial due to insufficient information to assess the risk to study subjects.[ Price : $8.95]
Former FDAer Timothy Cote asks FDA to suspend regulatory actions on all requests it has from Russian pharmaceutical and medical de...[ Price : $8.95]
FDA releases the FDA-483 with one observation issued following an inspection at OSRX, a Missoula, MT, sterile drug compounder.[ Price : $8.95]
FDA publishes the second in a planned series of four methodological guidances on patient-focused drug development.[ Price : $8.95]
Federal Register notice: FDA classifies the screw sleeve bone fixation device into Class 2.[ Price : $8.95]
FDA releases final guidance on CDRHs Appeals Processes that describes the processes available to stakeholders to seek supervisory ...[ Price : $8.95]
Pink Concussions asks FDA to revoke clearance for the SyncThink Eye-Sync as an aid in diagnosing concussions because it does not a...[ Price : $8.95]
Attorney and data scientist Bradley Thompson says FDA hasnt responded to his request for information on when it will start releasi...