01530oam 2200421Ia 450 991069882670332120090528140048.0(CKB)5470000002397601(OCoLC)355507735(EXLCZ)99547000000239760120090528d2001 ua 0enguran|||||||||txtrdacontentcrdamediacrrdacarrierGuidance for industry[electronic resource] submitting type V drug master files to the Center for Biologics Evaluation and ResearchRockville, MD :U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research,[2001]i, 5 pages digital, PDF fileTitle from PDF title page (viewed on May 28, 2009)."Draft guidance"."August 2001".Includes bibliographical references (p. 5).Guidance for industry Drug factoriesGovernment policyUnited StatesFiling systemsUnited StatesBiologicalsGovernment policyUnited StatesDrug factoriesGovernment policyFiling systemsBiologicalsGovernment policyCenter for Biologics Evaluation and Research (U.S.)GPOGPOGPOBOOK9910698826703321Guidance for industry3434577UNINA