LEADER 01489nam  2200385Ia 450 
001 9910696912203321
005 20230902161717.0
035   $a(CKB)5470000002383774
035   $a(OCoLC)567509206
035   $a(EXLCZ)995470000002383774
100   $a20100323d1999      ua             0
101 0 $aeng
135   $auran|||||||||
181   $ctxt$2rdacontent
182   $cc$2rdamedia
183   $acr$2rdacarrier
200 00$aGuidance for industry$b[electronic resource] $einterpreting sameness of monoclonal antibody products under the orphan drug regulations
210  1$aRockville, MD :$cU.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research :$cCenter for Drugs Evaluation and Research,$d[1999]
215   $a1 electronic resource (i, 5 pages)
300   $a"Draft guidance."
300   $a"July 1999."
320   $aIncludes bibliographical references ( page 5).
517   $aGuidance for industry 
606   $aMonoclonal antibodies$xTherapeutic use$xGovernment policy$zUnited States
606   $aOrphan drugs$zUnited States
615  0$aMonoclonal antibodies$xTherapeutic use$xGovernment policy
615  0$aOrphan drugs
712 02$aCenter for Biologics Evaluation and Research (U.S.)
712 02$aCenter for Drug Evaluation and Research (U.S.)
801  0$bGPO
801  1$bGPO
906   $aBOOK
912   $a9910696912203321
996   $aGuidance for industry$93434577
997   $aUNINA