Advanced Medical Technology Association says there are inconsistencies and ongoing concerns with FDAs guidance on remanufacturing/servicing medical de...
Regeneron calls on FDA to develop two guidances to further the use of precision medicine in non-oncology diseases.
Glenmark Pharmaceuticals recalls (Class 1) 114 batches of potassium chloride extended-release capsules, USP (750 mg), due to dissolution concerns.
A House subcommittee report claims that FDA cut corners in its usually rigorous processes and bowed to Biden Administration political pressure in appr...
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 ...
