Guidance for FDA reviews and sponsors
Subtitle: content and review of chemistry, manufacturing, and control (CMC) information for human gene therapy investigational new drug applications (INDs)
Publisher: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research
Published: 2008
Place of publication: Rockville, MD
Language: eng
Format: [electronic resource] :
Number of pages: 34
Subjects: Gene therapy; Drug approval
Other titles: Content and review of chemistry, manufacturing, and control (CMC) information for human gene therapy investigational new drug applications (INDs)
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.