US FDA

FDA is making optimal use of its financial resources to maximize its ability to efficiently and effectively deliver on its commitments to the public.

The OTC Monograph drug user fee program, which we refer to as “OMUFA,” is similar to our other user fee programs, such as the Prescription Drug User Fee Act (PDUFA).

This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have been granted for supportive care products and changes to dosing or formulation.

Certain lots of ViziShot 2 FLEX (19G) aspiration needles may have deformed a-traumatic tips that pose a risk to patient safety if they are used.

PDUFA VII Commitment: An Assessment of the Sentinel System (2022 to 2024)

Since the passage of the Prescription Drug User Fee Act (PDUFA) in 1992, user fees have played an important role in expediting the drug approval process while ensuring their safety and efficacy. PDUFA must be reauthorized every five years, and in September 2022, the President signed into law the six

FDA-TRACK: Biosimilar User Fee Act Procedural Response Goals Summary

Lawrence Wholesale LLC of Vernon, CA is recalling a limited quantity of Kroger bagged frozen shrimp and Kroger frozen shrimp products because they may have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with Cesium-137 (Cs-137).

Sprout Organics is expanding its September 16, 2025 recall of Sprout Organics® Sweet Potato Apple and Spinach, due to potentially elevated lead levels, to include additional lots.

FDA is announcing an Early Alert for Abiomed’s Automated Impella Controller due to Purge Pressure Issues

CGMP/Finished Pharmaceuticals/Adulterated

Unapproved New Drugs/Misbranded