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FDA releases the FDA-483 with 15 observations issued following an inspection at the Edmond, OK-based Qualgen outsourcing facility.[ Price : $8.95]
FDA issues a partial clinical hold on BioCryst clinical trial of its oral Factor D inhibitor, BCX9930 due to observed elevations i...[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension entitled Antimicrobial Animal Drug Distribution Repo...[ Price : $8.95]
Psychiatrist Brian Barnett says FDA should remove itself from neutrophil monitoring requirements for patients on clozapine and lea...[ Price : $8.95]
FDA publishes a guidance with recommendations for feasibility and early feasibility studies in medical devices intended to improve...[ Price : $8.95]
A House Energy and Commerce Committee legislative package to reauthorize FDA user fee agreements aims to address agency predicamen...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Clinical Pharmacology Considerations for Human Radiolabeled...[ Price : $8.95]
FDA clears a VideaHealth 510(k) for its Videa Caries Assist, an artificial intelligence-powered dental caries (cavity) detection a...