Clinical safety data management : definitions and standards for expedited reporting.

Bibliographic Details
Corporate Authors:	United States. Food and Drug Administration, International Conference on Harmonisation
Format:	Government Document Conference Proceeding eBook
Language:	English
Published:	[Rockville, Md.] : [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research], [1995]
Series:	Guideline for industry ; ICH-E2A.
Subjects:	Drugs > Dosage > United States. Drugs > Side effects > Reporting > Government policy > United States.
Online Access:	https://purl.fdlp.gov/GPO/LPS117315