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Guidance for industry : format and content of proposed risk evaluation and mitigation strategies (REMS), REMS assessments, and proposed REMS modifications
- Available as
- Online
Details
- Format
- Books
- Language
- English
- Contributors
- Publication
-
- Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2009]
- Physical Details
-
- 1 online resource (36 pages)
- data file
- OCLC
- ocn466874920
- "Draft guidance."
- "Drug safety."
- "September 2009."