Docket Number: FDA-2017-D-1105 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Office of the Commissioner, Office of […]

As part of the Accelerating Rare disease Cures (ARC) Program, CDER’s Rare Diseases Team (RDT) inaugurated the Learning and Education to Advance and Empower Rare Disease […]

On This Page Date: November 21, 2024 Time: 1:00 PM – 3:00 PM ET AGENDA Visit CDER Small Business and Industry Assistance Page ABOUT THIS EVENT […]

Product: Drugs Recipient: Recipient Name Gilad Wielunski Media Networks Sydney Pty Limited 36 Mid Dural RdGalston NSW 2159Australia [email protected] Issuing Office: Center for Drug Evaluation and […]

As part of the enhanced accountability and reporting commitments in the Generic Drug User Fee Amendments of 2017 (GDUFA II), FDA prepares annual outcome reports on […]

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, […]