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GUIDANCE DOCUMENT

Waivers of the Single, Shared System REMS Requirement; Draft Guidance for Industry May 2018

Draft

Not for implementation. Contains non-binding recommendations.

Waivers of the Single, Shared System REMS Requirement; Draft Guidance for Industry

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance describes how FDA intends to consider granting a waiver of the requirement in section 505-1(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355-1(i)) that the applicant for an abbreviated new drug application (ANDA) and its reference listed drug (RLD) use a single, shared system (SSS) for a required risk evaluation and mitigation strategy (REMS) with elements to assure safe use (ETASU).


Submit Comments

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.