Accuracy and integrity of establishment registration and drug listing data are essential to FDA’s mission. Several key programs inside and outside the agency such as inspections, […]

This web page provides information about the in vitro susceptibility of bacteria to certain drugs. The safety and efficacy of these drugs in treating clinical infections due to […]

Amikacin Injection FDA does not recognize MI00 standard (MIC and disk diffusion) for Enterobacterales and Pseudomonas aeruginosa Antibacterial 4/21/2023 Amoxicillin and clavulanate Oral FDA does not […]

Due to the COVID-19 pandemic, FDA has been closely monitoring the medical product supply chain with the expectation that it may be impacted by the COVID-19 […]

For Immediate Release: April 24, 2024 Today, the U.S. Food and Drug Administration approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary […]

Should you find a Web link (URL) embedded within guidance documents that does not work or other documents posted on the FDA Web site, please try […]

An abbreviated new drug application (ANDA) contains data which is submitted to FDA for the review and potential approval of a generic drug product. Once approved, […]

Drugs Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers Guidance for Industry Draft 4/24/2024 Generic Drugs Data Integrity for […]

12/05/2022 Thriftmaster Texas, LLC. d/b/a ThriftMaster Global Holdings, Inc. and TM Global Biosciences, LLC Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated […]