Related by context. Frequent words. (Click for all words.) 73 Prescription Drug User Fee 73 Act PDUFA 71 PDUFA date 56 FDA 55 Priority Review 53 NDA submission 52 CDER 52 Biologics License Application BLA 52 Hatch Waxman 50 Biologics License Application 50 Drug Administration FDA 50 sNDA 50 REMS 49 biosimilar 49 ANDAs 49 Bydureon 48 PhosLo 47 Marketing Authorization Application 47 New Drug Application 47 Complete Response Letter 47 Hatch Waxman Act 47 Afrezza 47 NUVIGIL 47 CHMP 46 Horizant 46 European Medicines Evaluation 46 INDs 46 Lumizyme 46 Opana ER 46 Glumetza 46 Complete Response letter 45 Biosimilars 45 approvable 45 Trexima 45 Contrave 45 orphan drug 45 biogenerics 45 Clolar 45 MNKD 45 Arzerra 45 approvable letter 45 Cubicin 45 Cinryze 45 Entereg 44 ANDA 44 sBLA 44 Orphan Drug Act 44 Kuvan 44 ATryn R 44 Xifaxan 44 Fast Track designation 44 USFDA 44 biosimilars 44 CDRH 44 Drug Administration 43 Victoza 43 DCGI 42 Investigational 42 Torisel 42 Acurox 42 Orphan Drug Designation 42 Drug Application 42 PPACA 42 Encysive 42 Treximet 42 biologics 42 Galvus 42 CoFactor 42 Renvela 41 Exanta 41 Welchol 41 ONXX 41 Orexigen 41 Thyrogen 41 Medicinal Products 41 NDAs 41 ustekinumab 41 ATryn 41 Board DSMB 41 Marketing Authorization Application MAA 41 Avanir 41 Aloxi 41 VPRIV 41 Rosiglitazone 41 formulary 41 clinical trials 40 pharmacovigilance 40 LLY 40 Medicare Modernization Act 40 Rimonabant 40 DNDN 40 postmarketing 40 Orphan Drug designation 40 END FOOTNOTE 40 calcitonin 40 Seroquel XR 40 Symlin 40 Ranexa 40 asenapine 40 USPTO 40 rulemaking