Reformulating Drug Products That Contain Carbomers Manufactured With Benzene Guidance 12/28/2023 NDA (new drugs), ANDA (generic drugs), DMF (drug master files), Drug Product, CGMP, Compendial Standards, […]

No. DrugName Active Ingredient Approval Date FDA-approved use on approval date* 59. Ultomiris ravulizumab 12/21/2018 To treat paroxysmal nocturnal hemoglobinuria (PNH)Press ReleaseDrug Trials Snapshot 58. Elzonris […]

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 […]