April 25, 2024

Impact Stories

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 […]
April 25, 2024

Pharmacy Compounding Advisory Committee Charter

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 […]
April 25, 2024


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 […]
April 24, 2024

Notice of Updates

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 […]
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