Issued by: Guidance Issuing Office Office of Inspections and Investigations BACKGROUND: On September 19, 1980, President Carter signed the Regulatory Flexibility Act, S. 229. This Act […]

Issued by: Guidance Issuing Office Human Foods Program Office of Inspections and Investigations Center for Drug Evaluation and Research BACKGROUND: There have been continuing problems concerning […]

Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (RO1)  Receipt Date: June 25, 2019 FOA Number: RFA-FD-20-001 Funding Opportunity Purpose: The purpose of […]

OOPD Background: The FDA Office of Orphan Products Development (OOPD) was created to identify and promote the development of orphan products. Orphan products are drugs, biologics, […]

On September 27, 2024, the Food and Drug Administration granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and pediatric patients 2 years […]

This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have been granted for supportive care products and changes to dosing or formulation. […]

HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this […]

Color Additives Approved for Use in Medical DevicesPart 73, Subpart D: Color additives exempt from batch certification 21 CFR Section Straight Color Year(2)Approved Uses and Restrictions […]

On This Page Date: March 5, 2024 Time: 9:00 AM – 3:30 PM ET Location: Event Location White Oak Campus: The Great RoomConference Center 10903 New […]