Guidance for industry : CGMP for phase 1 investigational drugs
Additional Titles
CGMP for phase 1 investigational drugs
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 : Office of Regulatory Affairs, [2008]
Title from PDF title page (viewed on Apr. 21, 2009). "July 2008."
Bibliography Note
Includes bibliographical references (page 17).
Technical Details
Mode of access: Internet at the FDA CBER Web site. Address as of 4/21/09: http://www.fda.gov/cber/gdlns/indcgmp.pdf ; current access is available via PURL.
Action Note
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