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Guidance Issuing OfficeCenter for Drug Evaluation and Research
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).
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2008-N-0281.