5017.8 Office of Pharmaceutical Quality Responsibilities for the Assessment of In Vitro Testing for Oral Drug Products Administered Via Enteral Feeding Tube Regulatory Review and Scientific […]

What is crowdsourcing? Crowdsourcing is the practice of asking the public for ideas, information, and opinions to help solve a problem in an innovative way or […]

In 2023 generic drugs continued to play a critical role in the U.S. health care system allowing patients greater access to needed medicines. Generic drugs are […]

Drug Shortages can occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. Manufacturers provide FDA most drug shortage information, and the agency works closely with them to prevent […]

Committee’s Official Designation Gastrointestinal Drugs Advisory Committee Authority The Gastrointestinal Drugs Advisory Committee (the Committee ) is established under 15 U.S.C. 1451 et seq.; 21 U.S.C. […]

The DMF Payments Received table summarizes total monthly counts of GDUFA Type II Active Pharmaceutical Ingredient (API) Drug Master File (DMF) payments according to the month and […]