01489nam 2200385Ia 450 991069691220332120230902161717.0(CKB)5470000002383774(OCoLC)567509206(EXLCZ)99547000000238377420100323d1999 ua 0enguran|||||||||txtrdacontentcrdamediacrrdacarrierGuidance for industry[electronic resource] interpreting sameness of monoclonal antibody products under the orphan drug regulationsRockville, MD :U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research :Center for Drugs Evaluation and Research,[1999]1 electronic resource (i, 5 pages)"Draft guidance.""July 1999."Includes bibliographical references ( page 5).Guidance for industry Monoclonal antibodiesTherapeutic useGovernment policyUnited StatesOrphan drugsUnited StatesMonoclonal antibodiesTherapeutic useGovernment policyOrphan drugsCenter for Biologics Evaluation and Research (U.S.)Center for Drug Evaluation and Research (U.S.)GPOGPOBOOK9910696912203321Guidance for industry3434577UNINA