On this page: American medicine cabinets contain a growing choice of nonprescription, over-the-counter (OTC) medicines to treat an expanding range of ailments. OTC medicines often do […]

Approved Active Moieties to which FDA has issued a Written Request for Pediatric Studies under Section 505A of the Federal Food, Drug, and Cosmetic Act NOTE: This list simply identifies […]

FOOD AND DRUG ADMINISTRATION MODERIZATION ACT OF 1997 [Page 111 STAT. 2296] Public Law 105-115 105th Congress SEC. 127. APPLICATION OF FEDERAL LAW TO PRACTICE OF […]

Submit Comments by 09/29/2024 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]

Below are frequently asked questions and the associated answers sorted by topic area.  Drug Review What information and types of notifications are provided to sponsors during […]

By: Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research and Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research CDER Director, Patrizia […]

FDA Opens Doors for More Treatments for Rare Diseases through the New START Pilot Program By: Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research […]

Image By: Robert M. Califf, MD, Commissioner of Food and Drugs During my career as an academic researcher, physician, and public health official, I’ve tried to […]

State-licensed physicians and pharmacists that compound under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) may only compound drug products using bulk […]