01443oam 2200385 a 450 991069872020332120120501083250.0(CKB)5470000002396657(OCoLC)319178291(EXLCZ)99547000000239665720090424d2008 ua 0engurbn|||||||||txtrdacontentcrdamediacrrdacarrierGuidance for FDA reviews and sponsors [electronic resource] content and review of chemistry, manufacturing, and control (CMC) information for human gene 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]1 online resource (ii, 34 pages)Title from title screen (viewed on Apr. 24, 2009)."April 2008".Includes bibliographical references (pages 32-34).Guidance for FDA reviews and sponsors Gene therapyDrug approvalUnited StatesGene therapy.Drug approvalCenter for Biologics Evaluation and Research (U.S.)GPOGPOGPOBOOK9910698720203321Guidance for FDA reviews and sponsors3492627UNINA