Developing New Drugs American consumers benefit from having access to the safest and most advanced pharmaceutical system in the world. The main consumer watchdog in this system is FDA's Center for Drug Evaluation and Research (CDER). The center's best-known job is to...

Find FDA-Recognized Susceptibility Test Interpretive CriteriaUpdates These web pages provide information about the in vitro susceptibility of bacteria or fungi to certain drugs. The safety and efficacy of these drugs in treating clinical infections due to such...

On This Page Date: September 24, 2025 Time: 9:00 a.m. - 12:00 p.m. ET The Food and Drug Administration (FDA) is holding a hybrid public meeting titled "Prescription Drug User Fee Act and Biosimilar User Fee Amendments Hiring and Retention Assessment." The meeting...

Guidance documents represent the Agency's current thinking on a particular subject. These documents are prepared for FDA review staff and applicants/sponsors to provide guidelines to the processing, content, and evaluation/approval of applications and also to the...

AUDIENCE: Patient, Health Care Professional, Pharmacy, Cardiology, Neurology, Internal Medicine, Family Practice, Travel ClinicsUPDATE: On August 22, 2025, the US FDA’s Center for Biologics Evaluation and Research (CBER) has suspended the biologics license for Valneva...