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Guidance for industry : addendum to E2C clinical safety data management : periodic safety update reports for marketed drugs.

Bibliographic Details
Corporate Authors: Center for Drug Evaluation and Research (U.S.), Center for Biologics Evaluation and Research (U.S.), 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 Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2004]
Subjects:
Clinical pharmacology.
Drugs > Side effects > Reporting.
Drugs > Testing.
Online Access:https://purl.fdlp.gov/GPO/LPS113936
Description
Item Description:Title from PDF title page (viewed on June 19, 2009).
"ICH".
"February 2004".
Electronic resource.
Physical Description:9 pages : digital, PDF file.
Format:Mode of access: Internet at the FDA web site. Address as of 6/19/09: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm129446.pdf ; current access is available via PURL.