TKTX Numbing Cream USA – 702106 – 02/25/2025

As part of the reauthorization of the Prescription Drug User Fee Act (PDUFA VII), FDA committed to reporting aggregate and anonymized information on submissions to the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER).

Alembic Pharmaceuticals Limited – 11/10/2021. Country: India. Record Type: 483

CGMP/Finished Pharmaceuticals/Adulterated

Certain reprocessed catheters may contain residual particulates that could cause infection, embolism, or thrombosis.

Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development

Learn how the FDA regulates drugs using science and data to ensure their safety, quality and efficacy. FDA plays a vital role in drug development and approval process. Watch our informative video series on FDA drugs, FDA approval, and the drug development process.