Federal Register notice: FDA determines that Janssen Pharmaceuticals Invega (paliperidone) extended-release tablet was not withdrawn from sale due to ...
FDA converts Janssens Sirturo (bedaquiline) from accelerated to traditional approval following a determination that a confirmatory trial verified clin...
FDA releases a guidance entitled Laboratory Developed Tests: Small Entity Compliance Guide.
FDA approves an Endotronix PMA for its Cordella Pulmonary Artery Sensor System for treating New York Heart Failure Class III heart failure patients.
The House Energy and Commerce Committee seeks additional inspection records from FDA after its analysis of the foreign drug inspection program found t...
FDA denies a 4/2023 petition that called on the agency to withdraw approval for Harmony Biosciences Wakix (pitolisant) and take other actions against ...
Federal Register notice: FDA makes available a draft guidance entitled Considerations in Demonstrating Interchangeability With a Reference Product: Up...
Federal Register notice: FDA makes available a final guidance entitled Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug o...
