Related by context. Frequent words. (Click for all words.) 77 Market Approval PMA 72 Investigational Device Exemption IDE 72 Investigational Device Exemption 71 PMA submission 69 Biologics License Application BLA 68 Marketing Authorization Application MAA 67 exemption IDE 66 Biologics License Application 66 Marketing Authorization Application 65 Pivotal Phase III 64 Augment Bone Graft 64 IND submission 64 BLA submission 64 Complete Response 63 FDA approvable letter 62 MONOVISC 62 Pivotal Trial 62 supplemental Biologics License Application 62 application sNDA 62 CORTOSS 62 sBLA 62 FDA Accepts 62 Humanitarian Device Exemption 61 New Drug Application 61 Genasense R oblimersen 61 Phase III Clinical Trial 61 NDA submission 61 Bone Graft 61 sNDA 60 VALSTAR 60 Complete Response letter 60 Phase III pivotal 59 PREOS 59 sodium Injection 59 Panzem R 59 registrational 59 Patient Enrollment 59 phase IIb clinical 59 BEMA TM Fentanyl 59 alvimopan 59 FDA Clearance 59 Omigard 59 pseudobulbar affect PBA 59 Investigational 58 phase IIa 58 Clinical Trial Application 58 Diabetic Macular Edema 58 Pirfenidone 58 postherpetic neuralgia PHN 58 Completes Enrollment 58 confirmatory Phase III 58 FIRAZYR 58 liprotamase 58 submitted Biologics License 58 Neo Urinary Conduit 58 placebo controlled Phase 57 Zelrix 57 Orphan Drug Status 57 Phase Ib clinical 57 QNEXA 57 New Drug IND 57 Orphan Drug status 57 Telavancin 57 Marketing Authorization 57 Clinical Trial Results 57 Pennsaid R 57 Aerosurf 57 Pivotal Phase 56 Phase III clinical 56 ComfortScan system 56 Phase IIb trials 56 Surgical Adhesive 56 Metastatic Melanoma 56 orphan designation 56 bazedoxifene 56 SPD# 56 PRECISE 56 CE Marked 56 LightTouch 56 pivotal Phase III 56 Phase 2b clinical 56 IIa trial 56 Phase 2a clinical 56 anticancer compound 55 Phase IIa trial 55 Altropane 55 ATryn R 55 Approvable Letter 55 Fast Track Designation 55 Rhucin ® 55 Topical Interferon Alpha 2b 55 Presents Positive 55 ATryn ® 55 Act PDUFA date 55 OTCQX RHHBY 55 injection USP 55 investigational 55 confirmatory Phase 3 55 Mutual Recognition Procedure 55 ICA # 55 OFIRMEV