LEADER 01353nam 2200373Ia 450 001 9910699352803321 005 20230902161950.0 035 $a(CKB)5470000002402388 035 $a(OCoLC)502243286 035 $a(EXLCZ)995470000002402388 100 $a20100128d1999 ua 0 101 0 $aeng 135 $auran||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aGuidance for industry$b[electronic resource] $equalifying for pediatric exclusivity under section 505A of the Federal Food, Drug, and Cosmetic Act 210 1$aRockville, MD :$cU.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research :$cCenter for Biologics Evaluation and Research,$d[1999] 215 $a1 online resource (ii, 22 pages) 300 $a"Procedural." 300 $a"Revised, September 1999." 517 $aGuidance for industry 606 $aPediatrics$zUnited States 606 $aDrug approval$zUnited States 615 0$aPediatrics 615 0$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 $a9910699352803321 996 $aGuidance for industry$93434577 997 $aUNINA