FDA Provides Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities During COVID-19

Advancing Real-World Evidence Program

Clinical projects of the Oncology Center of Excellence, 2023 Annual Report

Sponsor Responsibilities – Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies

CGMP/Finished Pharmaceuticals/Adulterated

Interviews with experts from FDA’s Center for Drug Evaluation and Research (CDER) on priorities, projects, and initiatives.

Since the passage of the Prescription Drug User Fee Act (PDUFA) in 1992, user fees have played an important role in expediting the drug approval process while ensuring their safety and efficacy. PDUFA must be reauthorized every five years, and in September 2022, the President signed into law the six