[embedded content] Español Learn more about why you may not need antibiotics when you’re sick and the problems antibiotics can cause if taken unnecessarily. Antibiotics are […]

To illustrate the unique value of CDER’s regulatory science investments we have developed a series of “impact stories” that describe recent  advances by our researchers and […]

COMMITTEE’S OFFICIAL DESIGNATION Pharmacy Compounding Advisory Committee AUTHORITY The Pharmacy Compounding Advisory Committee (the Committee) is required by section 503A and section 503B of the Federal […]

Tianeptine is not approved by the U.S. Food and Drug Administration for any medical use. Despite that, some companies are illegally marketing and selling products containing […]

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 […]