Guidance for industry : format and content of proposed risk evaluation and mitigation strategies (REMS), REMS assessments, and proposed REMS modifications.

Bibliographic Details
Corporate Authors:	Center for Drug Evaluation and Research (U.S.), Center for Biologics Evaluation and Research (U.S.)
Format:	Government Document eBook
Language:	English
Published:	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]
Subjects:	Drugs > Risk assessment > Government policy > United States. Biologicals > Risk assessment > Government policy > United States.
Online Access:	https://purl.fdlp.gov/GPO/LPS116717

Description
Item Description:	"Draft guidance." "Drug safety." "September 2009." Electronic resource.
Physical Description:	1 online resource (36 pages)