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.
|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|
|Statutes at Large||106 Stat. 4491|
|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.|
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.