Related by context. Frequent words. (Click for all words.) 63 Complete Response 62 FDA Accepts 62 Market Approval PMA 60 FDA Clearance 60 PMA submission 60 Investigational Device Exemption 60 Humanitarian Device Exemption 59 FDA Advisory Panel 58 Biologics License Application BLA 58 Marketing Authorization 57 Citizen Petition 57 Biologics License Application 57 FDA approvable letter 57 Complete Response letter 57 application sNDA 57 Pivotal Phase III 56 Fast Track Designation 56 supplemental Biologics License Application 56 Generic Version 56 Vilazodone 55 sBLA 55 Patient Enrollment 55 Marketing Authorization Application 55 FDA Approval 55 Clinical Trial Application 54 Positive Opinion 54 sNDA 54 Mutual Recognition Procedure 54 Extended Release 54 Orphan Drug status 54 Orphan Drug Status 54 Receives FDA Clearance 54 Pivotal Trial 54 k Clearance 54 Phase III Clinical Trial 54 Investigational Device Exemption IDE 54 orphan designation 53 Pirfenidone 53 Clinical Trial Results 53 Completes Enrollment 53 pseudobulbar affect PBA 52 New Drug Application 52 Telavancin 52 Drug Application 52 Drug Candidate 52 CE Marking 52 Cardiac Resynchronization Therapy 51 FIRAZYR 51 alvimopan 51 Xinlay 51 Full Prescribing Information 51 Marketing Authorization Application MAA 51 Receives CE 51 FDA Orphan Drug 51 Oral Solution 51 Drug Eluting Stent 51 ISTODAX 51 Approvable Letter 51 Cethromycin 51 FDA Clears 51 Panzem R 51 Complete Response Letter 51 MHLW 51 Phase III Trial 50 Final Approval 50 Augment Bone Graft 50 Orphan Drug designation 50 Vandetanib 50 BLA submission 50 Neurodex 50 Zelrix 50 Pennsaid R 50 prGCD 50 Orphan Drug Designation 50 PREOS 50 MitraClip R 50 approvability 50 IPLEX 50 Pivotal Phase 50 Drug Eluting Stents 50 Cladribine 49 Gestiva 49 Act PDUFA date 49 pediatric exclusivity 49 Shelf Registration Statement 49 Fast Track designation 49 FDA 49 USFDA approval 49 Avastin bevacizumab 49 Staff Determination Letter 49 submitted Biologics License 49 Prescribing Information 49 Overactive Bladder 49 SPD# 49 Issues Guidance 49 PRISTIQ 49 MONOVISC 49 Investigational 49 Icatibant 49 CE Marked 49 IND submission