Summary of Color Additives for Use in the United States in Foods, Drugs, Cosmetics, and Medical Devices

This list contains GDUFA facility payments received by the Agency. Data are extract from the User Fee System and GDUFA Facility User Fee Coversheets. The following table explains the terms used in the list:

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

The U.S. Food and Drug Administration (FDA) is providing this communication to increase awareness of recent updates to the product labeling of capecitabine (Xeloda) and fluorouracil (5-FU) related to risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency. All healthcare providers sho

Hubei JXBio Pharmaceutical Co., Ltd. – 3/14/2025. Country: China. Record Type: 483

In accordance with section 505A(e)(1) of the Act, as amended by FDAAA (Pub. L. No. 110-85), the following list identifies those approved drugs for which a pediatric exclusivity determination was made, on or after September 27, 2007.

CDER’s Manual of Policies and Procedures (MAPPs) are federal directives and documentation of internal policies and procedures.