Overview of PDUFA

September 30, 2002 marked the end of 10 years of FDA experience with PDUFA. PDUFA has provided FDA with additional revenue to hire more reviewers and support staff and upgrade its information technology systems to speed up the application review process for new drugs and biological products without compromising FDA's traditionally high standards for approval. Under PDUFA, FDA agreed to meet certain performance goals that apply to the review of original and resubmitted new product applications and efficacy and manufacturing supplements to approved applications. FDA also agreed to meet certain procedural and processing goals aimed at speeding-up drug development. These goals were designed to become increasingly more stringent each year. To date, FDA has met or exceeded nearly every review performance goal and most of the procedural and processing goals.

Introduction | PDUFA I Outcomes