Article content

PDUFA

Biotech traders do not want dead money sitting in a low volume, sideways trading stock and so biotech traders use catalysts. Biotech investing relies heavily on catalyst events like PDUFA events that move share prices higher. PDUFA dates are deadlines by which the FDA must review new drug applications.

The Prescription Drug User Fee Act (PDUFA) authorizes the FDA to collect fees from companies that produce certain human drug and biological products. PDUFA established three types of user fees: application fees, establishment fees, and product fees. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval process.

The final FDA decision to approve or not approve a new product occurs on the Prescription Drug User Fee Act (PDUFA) meeting date. The PDUFA date is the final step in the formal regulatory pathway.

PDUFA (Wikipedia)
Prescription Drug User Fee Act
Great Seal of the United States
Long title An Act to amend the Federal Food, Drug, and Cosmetic Act to authorize human drug application, prescription drug establishment, and prescription drug product fees and for other purposes.
Acronyms (colloquial) PDUFA, DSA
Nicknames Dietary Supplement Act of 1992
Enacted by the 102nd United States Congress
Effective October 29, 1992
Citations
Public law 102-571
Statutes at Large 106 Stat. 4491
Codification
Acts amended Federal Food, Drug and Cosmetic Act
Titles amended 21 U.S.C.: Food and Drugs
U.S.C. sections amended 21 U.S.C. ch. 9, subch. VII § 379g et seq.
Legislative history

The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. The Act provided that the FDA was entitled to collect a substantial application fee from drug manufacturers at the time a New Drug Application (NDA) or Biologics License Application (BLA) was submitted, with those funds designated for use only in Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) drug approval activities. In order to continue collecting such fees, the FDA is required to meet certain performance benchmarks, primarily related to the speed of certain activities within the NDA review process.

<< Back to Glossary Index

Picture of SOFI artificial intelligence

SOFI AI For Premium Members