IndulgeRx Brands, Inc – 703668 – 06/16/2025

Learn more about FDA’s Postmarketing Requirements and Commitments Searchable Database.

Unapproved New Drugs

FDA strongly encourages companies to continue to develop new, reliable ways to minimize animal testing and to provide the data necessary for the FDA to make a GRASE determination for sunscreen active ingredients.

CGMP/Finished Pharmaceuticals/Adulterated

This guidance clarifies the scope of FDA’s oversight of clinical decision support software intended for health care professionals (HCPs) as devices.

The Food and Drug Administration (FDA) is holding a hybrid public meeting titled “Prescription Drug User Fee Act and Biosimilar User Fee Amendments Hiring and Retention Assessment on 9/24/2025.