One Source Nutrition, Inc. Issues Voluntary Nationwide Recall of Vitality Capsules Due to Presence of Undeclared Sildenafil and Tadalafil

One Source Nutrition is voluntarily recalling all lots of Vitality capsules to the Consumer level. FDA analysis has found the…

Generic Drugs Forum (GDF) 2025 – 04/09/2025

Join us at the annual Generic Drugs Forum, a two-day event designed to facilitate the development and approval of safe,…

Meeting Presentations | Drugs

Meeting Presentations. CDER professionals participate in several meetings, conferences and workshops throughout the year. Appealing primarily to the pharmaceutical industry…

Reorganization of the Office of New Drugs with Corresponding Changes to the Office of Translational Sciences and the Office of Pharmaceutical Quality

The New Drugs Regulatory Program Modernization’s reorganization of the Office of New Drugs (OND), with corresponding changes to the Office…

Frequently Asked Questions on Benzene Contamination in Drugs

FDA provides answers to frequently asked questions on benzene contamination in drugs

FDA Drug Safety Communication: FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change to inform of possible increased risk of heart attack and stroke with use

[03-03-2015] The U.S. Food and Drug Administration (FDA) cautions that prescription testosterone products are approved only for men who have…

FDA Roundup: February 28, 2025

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

FDA issues class-wide labeling changes for testosterone products

FDA issues labeling changes for all testosterone products following conclusion of ambulatory blood pressure monitoring studies and TRAVERSE trial,

Generic Drugs Program Activities Report – FY 2024 Monthly Performance

This report provides monthly activities metrics for the FDA Generic Drugs Program, outlining agency actions on abbreviated new drug applications.…

Generic Drugs Program Monthly and Quarterly Activities Report

Monthly and quarterly metrics of the FDA Generic Drugs Program.