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Guidance for industry : submitting marketing applications according to the ICH-CTD format, general considerations.

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, [2001]
Subjects:
Drug approval.
Drugs > Marketing.
Clinical trials > Reporting.
Online Access:https://purl.fdlp.gov/GPO/LPS114307
Description
Item Description:Title from PDF title page (viewed on July 2, 2009).
"Procedural".
"August 2001".
Electronic resource.
Physical Description:13, 1, 2 pages : digital, PDF file.
Format:Mode of access: Internet at the FDA web site. Address as of 7/2/09: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm129720.pdf ; current access is available via PURL.