Mobile Lift Component Recall: Baxter Healthcare Corporation Removes Mobile Lift Component due to Risk of Improper Attachment

Monthly and quarterly metrics of the FDA Generic Drugs Program.

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.

To help address challenges associated with ensuring data quality and integrity in regulated studies conducted in BSL-4 laboratories to support MCM development, FDA and UTMB collaborate to provide an annual training course on how to meet GLP requirements in BSL-4 facilities

FDA encourages the early adoption of advanced manufacturing technologies (AMTs) that have the potential to benefit patients by improving manufacturing and supply dependability and optimizing development time of drug and biological products.

CGMP/Finished Pharmaceuticals/Adulterated

OPS Environmental Impact Review at CDER: ENVIRONMENTAL IMPACT: CLAIMS FOR CATEGORICAL EXCLUSION