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Guidance for industry : format and content of proposed risk evaluation and mitigation strategies (REMS), REMS assessments, and proposed REMS modifications.
Connect to full text Available online
View online- Format:
- Book
- Government document
- Language:
- English
- Subjects (All):
- Drugs--Risk assessment--Government policy--United States.
- Drugs.
- Biologicals--Risk assessment--Government policy--United States.
- Biologicals.
- Biological products--Risk assessment--Government policy--United States.
- Biological products.
- United States.
- Physical Description:
- 1 online resource (36 pages)
- Other Title:
- Format and content of proposed risk evaluation and mitigation strategies (REMS), REMS assessments, and proposed REMS modifications
- Place of 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]
- Notes:
- "Draft guidance."
- "Drug safety."
- "September 2009."
- OCLC:
- 466874920
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