Year: 1997
Type: report
Abstract: The Prescription Drug User Fee Act of 1992 (PDUFA) enabled the Food and Drug Administration (FDA) to assess user fees on research-based pharmaceutical companies to be used solely to accelerate the process for reviewing and approving applications for new drugs.In at least two respects there have tangible accomplishments.First, since 1993, one-third less time was required to review and approve new research-based drugs than in the years prior to PDUFA implementation.Second, the number of new drugs approved by FDA rose by one-third.But PDUFA was not intended to and does not address other related issues of the total regulatory process for new drug development and approval, pricing of new drugs, or the approval of generic drugs.
Author: David J. Cantor
Language: English
Subfield: Economics and Econometrics
Domain: Social Sciences
Open Access status: green
OpenAlex ID: W213853479