01397nam 2200385Ia 450 991069692250332120230902161730.0(CKB)5470000002383670(OCoLC)558728732(EXLCZ)99547000000238367020100318d1997 ua 0enguran|||||||||txtrdacontentcrdamediacrrdacarrierGuidance for industry[electronic resource] changes to an approved application for specified biotechnology and specified synthetic biological products[Rockville, MD] :U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research :Center for Drug Evaluation and Research,[1997]1 electronic research (i, 8 pages)"July 1997."Guidance for industry BiotechnologyUnited StatesBiologicalsUnited StatesDrug approvalUnited StatesBiotechnologyBiologicalsDrug approvalCenter for Drug Evaluation and Research (U.S.)Center for Biologics Evaluation and Research (U.S.)GPOGPOBOOK9910696922503321Guidance for industry3434577UNINA