Related by context. Frequent words. (Click for all words.) 66 Market Approval PMA 66 PMA submission 66 Investigational Device Exemption 65 Marketing Authorisation 63 Complete Response 63 FDA Clearance 63 FDA Accepts 62 Confirmatory 62 CORTOSS 62 Combidex 62 Marketing Authorization 62 Orphan Drug Status 62 CryoSeal FS System 61 CE Marked 61 supplemental Biologics License Application 61 Investigational Device Exemption IDE 60 CHMP recommendation 60 Fast Track Designation 60 Biologics License Application 60 Pivotal Phase III 60 AdreView 60 Marketing Authorization Application 60 IND Investigational New 60 Humanitarian Device Exemption 60 Pivotal Trial 60 Pennsaid R 59 Drug Submission 59 k Clearance 59 LVAS 59 exemption IDE 59 Biologics License Application BLA 59 ISTODAX 59 BLA submission 58 orphan designation 58 Microvolt T Wave Alternans 58 CE Marking 58 Receives FDA Clearance 58 Augment Bone Graft 58 BrachySil 58 License Application 58 IND submission 58 Infusion System 58 orphan medicinal product 58 Application BLA 57 Roflumilast 57 Priority Review 57 IPLEX 57 VALSTAR 57 Initiate Phase 57 VIAject 57 Announces FDA Clearance 57 PhosLo 57 Phase IIB 57 ZEGERID Capsules 57 rhBMP 2 57 ARCOXIA 57 Excellagen 57 ComfortScan system 57 FDA Approval 57 M Enoxaparin 57 Initiates Phase II 56 OsmoPrep 56 Orphan Drug status 56 desvenlafaxine 56 Clinical Trial Application 56 Hexvix 56 PREOS 56 Omigard 56 Hyperthermia System 56 NeutroSpec 56 Privigen 56 rhThrombin 56 sBLA 56 Amyvid 56 Zelrix 56 FIRAZYR 56 OMS#HP 56 Soliris TM eculizumab 56 refractory chronic lymphocytic 56 Bone Graft 56 Phase III Clinical Trial 56 Receives CE 56 Junovan 56 FFDCA 56 application sNDA 56 Investigational 56 Complete Response letter 56 carotid stent 56 ATryn ® 56 Marketing Authorization Application MAA 56 Act PDUFA date 56 FDA Clears 55 PTCRB 55 dalbavancin 55 Recombinant Human 55 FDA approvable letter 55 Thrombin 55 Final Approval 55 AlloMap 55 MHLW 55 Powerlink System