Issue Date: October 7, 2008
Issued by: Center for Drug Evaluation and Research
Topic(s):
Status: Final
PDUFA Pilot Project: Proprietary Name Review – Concept Paper
On September 27, 2007, President Bush signed into law the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85, 121 Stat. 823 (FDAAA), which includes the reauthorization and expansion of the Prescription Drug User Fee Act (PDUFA IV).
Download the Guidance Document
