This guidance provides information on how the FDA will define and process submissions from application holders2 for modifications and revisions3 to approved risk evaluation and mitigation strategies (REMS). Specifically, this guidance provides information on what types of changes to REMS will be considered modifications of the REMS, as described in section 505-1(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and what types of changes will be considered revisions of the REMS.5 There are different procedures for submission of REMS modifications and revisions to the FDA, as well as different time frames for FDA review and action on such changes. This guidance provides information on how REMS modifications and revisions should be submitted to the FDA, and the FDA’s process for reviewing and acting on these submissions. The definitions of REMS modifications and revisions set forth in this 30 guidance apply to all types of REMS. This guidance is issued pursuant to sections 505 31 1(h)(2)(A)(ii), (iii), and (iv) of the FD&C Act.
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.