Upgrading Category III Antiperspirants to Category I (43 FR 46728-46731)
The guidelines recommended in this document for the studies required to bring a Category III antiperspirant drug product into Category I are in accord with the present state of the art and do not preclude the use of any advances or improved technology in the future.
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:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.