Related by context. Frequent words. (Click for all words.) 78 Act PDUFA 73 PDUFA 71 Act PDUFA date 65 PDUFA date 59 Priority Review 53 pediatric exclusivity 52 Complete Response 51 Biologics License Application BLA 51 Hatch Waxman 50 Biologics License Application 49 alogliptin 48 sNDA 48 Hatch Waxman Act 48 European Medicines Evaluation 48 NUVIGIL 47 Exalgo 47 sBLA 47 orphan designation 47 FDA 47 biosimilar 47 Clolar 47 Drug Administration FDA 47 Fast Track designation 46 CDER 46 Marketing Authorization Application 46 REMS 46 Mitigation Strategy REMS 46 Complete Response letter 45 Orphan Drug status 45 Lumizyme 45 alvimopan 45 ATryn R 45 Complete Response Letter 45 Orphan Drug designation 45 New Drug Application 44 orphan medicinal product 44 Arzerra 44 Biosimilars 44 Horizant 44 NDA submission 44 Project Bioshield 44 Marketing Authorization Application MAA 44 investigational compound 44 See BioWorld Today 44 ONSOLIS 43 Tygacil 43 Citizen Petition 43 Research CDER 43 Folotyn 43 Medicare Modernization Act 43 Saphris 43 Krystexxa 43 Medicinal Products 43 Metabolic Drugs Advisory 42 Vilazodone 42 ANDAs 42 Treximet 42 VIMOVO 42 PREOS 42 Marketing Authorization 42 CHMP 42 INDs 41 Stelara 41 Abstral 41 LIALDA 41 biogeneric 41 Promacta 41 Drug Administration 41 Renewable Fuels Standard 41 Xifaxan 41 GPhA 41 Thyrogen 41 Rhucin ® 40 Consolidated Appropriations 40 GMPs 40 Genetic Information Nondiscrimination 40 CHMP opinion 40 Trexima 40 Drug Application 40 Contrave 40 bazedoxifene 40 biogenerics 40 Omnitrope 40 Indiplon 40 ustekinumab 40 Regulatory Flexibility Act 40 Mylotarg 40 SCOLR 39 Kuvan 39 European Medicines Agency 39 Comparative Effectiveness Research 39 Emergency Economic Stabilization 39 PL #-# [001] 39 SFDA approval 39 SFDA 39 setantasports.com staff 39 Upsher Smith 39 Real Estate Settlement Procedures 39 Oli Skehan 39 VPRIV 39 investigational