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).
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.