Use of a Drug Master File for Shared System REMS Submissions Guidance for Industry November 2017
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and Research
Guidance for Industry
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2017-D-6231.