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Subjects
Gene therapy, Drug approvalPlaces
United StatesShowing 1 featured edition. View all 1 editions?
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Guidance for FDA reviews and sponsors: content and review of chemistry, manufacturing, and control (CMC) information for human gene therapy investigational new drug applications (INDs)
2008, U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research
electronic resource :
in English
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Edition Notes
Title from title screen (viewed on Apr. 24, 2009).
"April 2008".
Includes bibliographical references (p. 32-34).
Mode of access: Internet at the GPO Web site. Address as of 4/24/09: http://www.fda.gov/cber/gdlns/gtindcmc.pdf ; current access is available via PURL.
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