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001 9910690381003321
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035   $a(CKB)5470000002337480
035   $a(OCoLC)496287106
035   $a(EXLCZ)995470000002337480
100   $a20100108d1995      ua             0
101 0 $aeng
135   $auran|||||||||
181   $ctxt$2rdacontent
182   $cc$2rdamedia
183   $acr$2rdacarrier
200 00$aGuidance for industry$b[electronic resource] $econtent and format of investigational new drug applications (INDs) for phase 1 studies of drugs, including well-characterized, therapeutic, biotechnology-derived products
210  1$a[Rockville, MD] :$cCenter for Drug Evaluation and Research :$cCenter for Biologics Evaluation and Research,$d[1995]
215   $a1 online resource (i, 16 pages)
300   $a"November 1995."
320   $aIncludes bibliographical references (pages 15-16).
517   $aGuidance for industry 
606   $aDrugs$xTesting$xGovernment policy$zUnited States
606   $aPharmaceutical biotechnology$xGovernment policy$zUnited States
615  0$aDrugs$xTesting$xGovernment policy
615  0$aPharmaceutical biotechnology$xGovernment policy
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
801  2$bGPO
906   $aBOOK
912   $a9910690381003321
996   $aGuidance for industry$93434577
997   $aUNINA