Captain Kendra Stewart, Orange Book supervisor, discusses the Orange Book’s 40th Anniversary October 31, 2020, marks the 40th anniversary of the first official publication of the […]

[August 8, 2023] – The agency has not identified any diethylene glycol (DEG) and ethylene glycol (EG) contamination within the U.S. and will continue to enforce […]

By: Theresa Mullin, Ph.D., CDER’s Associate Center Director for Strategic Initiatives, and Michael Kopcha, Ph.D., R.Ph., director of CDER’s Office of Pharmaceutical Quality FDA and the […]

Generic medications are safe and effective, just as their brand-name counterparts, and often cost less, providing consumers and the healthcare system significant savings. Lack of awareness […]

FDA’s requirements for approval of new drugs, generic drugs, and biologics are among the highest standards across the globe. Prior to FDA approval, manufacturers of prescription […]

FDA regulates sunscreens, which are nonprescription drugs, to help make sure that consumers have access to safe and effective sun protection products. There have been several […]

I’m pleased to have this opportunity to help kick off this year’s Global Summit on Regulatory Science. I’m sorry I can’t be with you in person. […]

For Immediate Release: March 15, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]

On This Page Description:  This workshop will bring together leaders and subject matter experts from regulatory agencies, industry, and academia to discuss critical topics related to […]