CDER Small Business & Industry Assistance (SBIA)

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:

The U.S. Food and Drug Administration, under a cooperative agreement with the Duke-Margolis Institute for Health Policy, is hosting the 16th Annual Sentinel Initiative Public Workshop on November 6, 2025

The Data Standards Strategy reinforces CDER’s ongoing commitment to the development, implementation, and maintenance of a comprehensive data standards program that will facilitate the efficient and effective review of regulatory submissions. This helps bring safe and effective products to market.

National Drug Code Database Background Information

Abbreviated New Drug Applications and following the path to generic drug approval. Generic drug applications are termed “abbreviated” because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, generic applicants

The Food and Drug Administration is advising consumers not to purchase or use VITAFER-L Gold 20ml, a product promoted for energy and sexual enhancement on various websites, including www.amazon.com.