The process of implementing this section of FDAMA was logically divided into two stages. During the first stage, existing guidance was identified and evaluated to assess whether it was adequate, whether additional guidance was needed or whether there was insufficient information at this time to make such a determination. The outcome of this first stage would dictate whether another stage, which might include gathering additional data and drafting additional guidance, would be needed.
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.