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FDA converts Janssens Sirturo (bedaquiline) from accelerated to traditional approval following a determination that a confirmatory...[ Price : $8.95]
FDA releases a guidance entitled Laboratory Developed Tests: Small Entity Compliance Guide.[ Price : $8.95]
FDA approves an Endotronix PMA for its Cordella Pulmonary Artery Sensor System for treating New York Heart Failure Class III heart...[ Price : $8.95]
The House Energy and Commerce Committee seeks additional inspection records from FDA after its analysis of the foreign drug inspec...[ Price : $8.95]
FDA denies a 4/2023 petition that called on the agency to withdraw approval for Harmony Biosciences Wakix (pitolisant) and take ot...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Considerations in Demonstrating Interchangeability With a R...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Circumstances That Constitute Delaying, Denying, Limiting, ...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Human User Safety in New and Abbreviated New Animal Drug Ap...