The Prescription Drug User Fee Act (PDUFA) is a law enacted by Congress that gives powers to the FDA.
Amongst other things the law allows the FDA to charge drugmakers to review their New Drug Applications or Biologics License Application. The FDA uses this money to speed up the review process. A typical review time is 10 months for a standard review or six months for an expedited review. The term "PDUFA date" comes from these waiting times, but is not really a deadline; the FDA tries to complete its review by the PDUFA date, but has handed down its ruling after the PDUFA date many times.
The version signed into law on September 27, 2007, was the fourth iteration of PDUFA and gave the FDA more powers to review the safety of drugs after marketing approval.
Related Fool Articles
Recent Mentions on Fool.com
- Healthcare's Trick or Treats: What We're Watching in October
- 3 Biotech Stocks Short-Sellers Have Targeted the Most
- What Stock Market Correction? These Biotech Stocks Recently Hit 52-Week Highs
- Will the FDA Approve All 3 of These Cancer Drugs in October?
- The Market Swooned, but Sarepta Therapeutics Soared in August
- Why Opko Health Lost More Than a Third of Its Value Last Month