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).

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).

Bibliographic Details
Corporate Author: 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 Biologics Evaluation and Research, [2008]
Subjects:
Gene therapy.
Drug approval > United States.
Online Access:https://purl.fdlp.gov/GPO/LPS111884

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