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Last updated 1 day ago

Global Generic Drug Affairs

1 day ago

FDA’s Office of Generic Drugs (OGD) ensures, through a scientific and regulatory...

October 29, 2024: Meeting of the Pharmacy Compounding Advisory Committee - 10/29/2024

1 day ago

This meeting is scheduled to start at approximately 8 a.m. Eastern Time...

Opportunities to Improve Dose-Finding and Optimization for Rare Disease Drug Development - 10/29/2024

1 day ago

U.S. Food and Drug Administration, under a cooperative agreement with the Duke-Margolis...

Pharmaceutical Science and Clinical Pharmacology Advisory Committee Roster

1 day ago

This page contains the Pharmaceutical Science and Clinical Pharmacology Advisory Committee roster...

Biosimilar Product Information

1 day ago

This page includes a chart of the approved biosimilar and interchangeable products...

Navigating the Transition to Low Global Warming Potential Propellants - 12/04/2024

1 day ago

The purpose of this two-day workshop is to engage subject matter experts...

Recently Issued Guidance Documents

1 day ago

This page lists Recently Issued CBER and Cross-Center Guidance Documents.

We Are Hiring

1 day ago

FDA/CDER employment opportunities utilizing the FDA 21st Century Cures Act Hiring Authority

Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide

2 days ago

Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide

Consumer Updates

2 days ago

Science-based health and safety information you can trust.

Guidance Recap Podcast | Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development

2 days ago

Guidance Recap Podcast | Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in...

Regulatory Pharmaceutical Fellowship Program

3 days ago

Explore the FDA’s Regulatory Pharmaceutical Fellowship Program, a partnership with academia and...