What is pdufa?

The Prescription Drug User Fee Act (PDUFA) is a law passed by the United States Congress in 1992, which aims to enhance the process of drug approval by the U.S. Food and Drug Administration (FDA).

Under PDUFA, pharmaceutical companies must pay user fees to the FDA in exchange for a timely review of their new drug applications. These fees are used to enhance the FDA's resources and capabilities to ensure faster and better reviews of drug applications.

PDUFA has helped in reducing the time taken by the FDA to approve new drugs, which has resulted in faster access to new treatments for patients. The law has also increased transparency in the drug approval process, by requiring the FDA to provide regular updates on its review process to the public.

Since its implementation, PDUFA has been reauthorized several times, with the most recent reauthorization taking place in 2020. The current version of PDUFA aims to address several new challenges faced by the FDA, including the need to regulate digital health technology and promote drug development for rare diseases.