Related by context. Frequent words. (Click for all words.) 54 approvable letter 51 resubmission 49 FDA 47 Priority Review 47 sNDA 47 Bydureon 47 PDUFA date 46 Entereg 46 NDA submission 46 Complete Response Letter 45 PDUFA 45 Ranexa 44 sBLA 44 Marketing Authorization Application 44 investigational 44 Clolar 44 CHMP 43 Pristiq 43 bioequivalence 42 Drug Administration FDA 42 Trexima 42 Treximet 42 Galvus 42 Lumizyme 42 Marketing Authorization Application MAA 41 Prexige 41 efficacious 41 Drug Application 41 FDA reviewers 41 Xifaxan 41 REMS 41 Contrave 41 Cubicin 40 Xarelto 40 Exanta 40 Drug Administration 40 Act PDUFA 39 European Medicines Agency 39 ANDAs 39 Actemra 38 Galson 38 Orexigen 37 USFDA 37 Acurox 37 Serevent 37 DCGI 37 CDRH 37 Victoza 37 clinical trials 37 Evista 36 Prescription Drug User Fee 36 Medicinal Products 36 AMAG 36 biosimilar 36 Von Eschenbach 36 Tykerb 36 Effient 36 rehearing 35 Cinryze 35 Fentora 35 Medsafe 35 USPTO 35 Avanir 35 EFSA 35 Encysive 35 clinical trial 35 Zelnorm 34 liver toxicity 34 ATryn 34 Ketek 34 Drug Evaluation 34 Tysabri 34 MHRA 34 Benlysta 34 Xiaflex 34 resubmitting 33 Xolair 33 adequately capitalized 33 reconsideration 33 Prescribing Information 33 Vivus 33 Ampyra 33 acceptable 33 BioMimetic 32 inhalable 32 FSANZ 32 Intrinsa 32 nonresponsive 32 FDA Approval 32 compliant 32 approvals 32 resubmit 32 Xience 32 resolvable 32 von Eschenbach 32 resubmitted 32 economically feasible 32 biogenerics 32 postmarketing 31 application 31 achievable