Related by context. Frequent words. (Click for all words.) 57 Swissmedic 51 orphan designation 50 Orphan Drug designation 49 Marketing Authorization 49 Therapeutic Products 48 Marketing Authorization Application 48 voclosporin 47 PREOS 47 Biologics License Application 47 Orphan Drug status 46 alvimopan 46 Abstral 46 Investigational 46 sBLA 46 Scientific Advice 46 Investigational Device Exemption IDE 46 confirmatory Phase III 46 SFDA approval 45 Fast Track Designation 45 Marketing Authorization Application MAA 45 IND enabling 44 Orphan Drug Designation 44 MOZOBIL 44 European Medicines Evaluation 44 CE Marking 44 Biologics License Application BLA 44 regulatory approval 43 ATryn R 43 DAVANAT ® 43 taliglucerase alfa 43 Regulatory Approval 43 methylnaltrexone 43 Phase IIa clinical trials 43 sNDA 43 alogliptin 43 INDs 43 Act PDUFA date 43 Rhucin ® 42 clinical trials 42 Drug Application 42 DRAXIS 42 velaglucerase alfa 42 GMP certification 42 Loramyc ® 42 Cannasat 42 FDA Approval 41 submittal 41 Exalgo 41 Neuromed 41 GRAS status 41 Phenoptin 41 Phase III clinical trials 41 Complete Response letter 40 Fast Track designation 40 Approvable Letter 40 Pharmaxis 40 NDA submission 40 Ceplene R 40 StaphVAX 39 NovaDel 39 CHMP opinion 39 vitro diagnostic IVD 39 Promacta 39 commercialization 39 L DOS# 38 BENLYSTA 38 Rhucin 38 Relistor 38 talactoferrin 38 Final Approval 38 PDUFA date 38 Phase III trials 38 New Drug Application 38 regulatory approvals 38 Vasovist 38 SILENOR TM 37 vernakalant iv 37 Approval 37 KRYSTEXXA 37 pralatrexate 37 Mozobil 37 Ceplene ® 37 MacroChem 37 Zerenex 37 SEROQUEL XR 37 Replagal 37 Bronchitol 37 Gestiva 36 aztreonam lysine 36 ANDA 36 requisite regulatory approvals 36 OFIRMEV 36 Cellegy 36 pediatric exclusivity 36 orphan drug 36 Priority Review 36 approvals 36 licensure 36 orBec R 36 Elaprase 36 Omnitrope