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100   $a20100318d1997      ua             0
101 0 $aeng
135   $auran|||||||||
181   $ctxt$2rdacontent
182   $cc$2rdamedia
183   $acr$2rdacarrier
200 00$aGuidance for industry$b[electronic resource] $echanges to an approved application for specified biotechnology and specified synthetic biological products
210  1$a[Rockville, MD] :$cU.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research :$cCenter for Drug Evaluation and Research,$d[1997]
215   $a1 electronic research (i, 8 pages)
300   $a"July 1997."
517   $aGuidance for industry 
606   $aBiotechnology$zUnited States
606   $aBiologicals$zUnited States
606   $aDrug approval$zUnited States
615  0$aBiotechnology
615  0$aBiologicals
615  0$aDrug approval
712 02$aCenter for Drug Evaluation and Research (U.S.)
712 02$aCenter for Biologics Evaluation and Research (U.S.)
801  0$bGPO
801  1$bGPO
906   $aBOOK
912   $a9910696922503321
996   $aGuidance for industry$93434577
997   $aUNINA