What is Artificial Intelligence and Machine Learning? Artificial Intelligence (AI) and Machine Learning (ML) can be described as a branch of computer science, statistics, and engineering […]

Helping Guide the Way for New Medicines Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s […]

Helping Guide the Way for New Medicines Innovative drugs often mean new treatment options for patients and advances in health care for the American public. When […]

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 […]