01515nam 2200397Ia 450 991069872050332120090424152922.0(CKB)5470000002396654(OCoLC)319176343(EXLCZ)99547000000239665420090424d2008 ua 0enguran|||||||||txtrdacontentcrdamediacrrdacarrierGuidance 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)Rockville, MD :U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research,[2008]ii, 36 pages digital, PDF fileTitle from PDF title page (viewed on Apr. 24, 2009)."April 2008".Includes bibliographical references (pages 27-29).Guidance for FDA reviews and sponsors Somatic cellsCellular therapyUnited StatesDrug approvalUnited StatesSomatic cells.Cellular therapyDrug approvalCenter for Biologics Evaluation and Research (U.S.)GPOGPOBOOK9910698720503321Guidance for FDA reviews and sponsors3492627UNINA