Related by context. Frequent words. (Click for all words.) 59 Orphan Drug Act 59 Act PDUFA date 56 Fast Track designation 55 Prescription Drug User Fee 55 Hatch Waxman Act 55 orphan designation 55 pediatric exclusivity 55 Orphan Drug status 55 Act PDUFA 55 Orphan Drug Designation 54 DSHEA 54 CGMP 54 Hatch Waxman 54 Elesclomol 54 Fast Track Designation 54 Biosimilars 54 Investigational Device Exemption 54 Pirfenidone 54 Safe GRAS 53 FDA 53 Omnitrope 53 Icatibant 53 Priority Review 53 Humanitarian Device Exemption 53 FDA Accepts 53 Dietary Supplement Health 52 Generally Recognized 52 Boxed Warning 52 Onsolis 52 Orphan Drug Status 52 Bevacizumab 52 FIRAZYR 52 orphan medicinal product 52 Mutual Recognition Procedure 52 PDUFA 52 BrachySil 52 QbD 52 QTDP 51 Bioterrorism Act 51 FIFRA 51 optical biosensors 51 Emend 51 Medicare Modernization Act 51 Orphan Drug designation 51 NeutroSpec 51 CAMR 51 BLA submission 51 Mitigation Strategy REMS 51 prGCD 51 Extended Release 51 Controlled Substances 51 GRAS status 51 REMS 51 Hycamtin 51 Regulatory Flexibility Act 51 CE Marked 50 CFATS 50 Acquisition Regulation FAR 50 Biologics License Application BLA 50 etravirine 50 Physician Payment 50 Afluria 50 America COMPETES Act 50 NOXAFIL 50 PREZISTA 50 Zolinza 50 Pharmacopeia USP 50 Torisel 50 Biomass Crop Assistance Program 50 Zelrix 50 liprotamase 50 alvimopan 50 Rev. Proc 50 Tygacil 50 Everolimus 50 IND submission 50 Federal Insecticide Fungicide 50 dalbavancin 50 Drug Application 50 Telavancin 50 GMPs 49 biogeneric 49 Marketing Authorization 49 BioDelivery Sciences 49 Isotretinoin 49 pancreatic enzyme 49 Azedra 49 orphan drug 49 Notice #-# [001] 49 Phase III Clinical Trial 49 Drug Administration FDA 49 Section #D 49 CE Marking 49 ONSOLIS 49 Biologics License Application 49 biogenerics 49 FDCA 49 FENTORA 49 investigational 49 ATryn ® 49 oral anticoagulant