LEADER 01580oam  2200409Ia 450 
001 9910697010803321
005 20230902162115.0
035   $a(CKB)5470000002384798
035   $a(OCoLC)426052505
035   $a(EXLCZ)995470000002384798
100   $a20090716d2004      ua             0
101 0 $aeng
135   $auran|||||||||
181   $ctxt$2rdacontent
182   $cc$2rdamedia
183   $acr$2rdacarrier
200 00$aGuidance for industry and FDA staff$b[electronic resource] $esubmission and resolution of formal disputes regarding the timeliness of premarket review of a combination product
210  1$aRockville, MD :$cU.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Combination Products,$d[2004?]
215   $a7 pages $cdigital, PDF file
300   $aTitle from PDF title page (viewed on July 16, 2009).
300   $a"05/2004"--Online title index.
517   $aGuidance for industry and FDA staff 
606   $aDispute resolution (Law)
606   $aDrug approval$xGovernment policy$zUnited States
606   $aChemotherapy, Combination
615  0$aDispute resolution (Law)
615  0$aDrug approval$xGovernment policy
615  0$aChemotherapy, Combination.
712 02$aUnited States.$bFood and Drug Administration.$bOffice of Combination Products.
712 02$aCenter for Biologics Evaluation and Research (U.S.)
801  0$bGPO
801  1$bGPO
801  2$bGPO
906   $aBOOK
912   $a9910697010803321
996   $aGuidance for industry and FDA staff$93451983
997   $aUNINA