Guidance for FDA reviews and sponsors [electronic resource] : content and review of chemistry, manufacturing, and control (CMC) information for human somatic cell therapy investigational new drug applications (INDS).
Imprint
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2008]
Content and review of chemistry, manufacturing, and control (CMC) information for human somatic cell therapy investigational new drug applications (INDS)
