Related by context. Frequent words. (Click for all words.) 69 PMA submission 69 Investigational Device Exemption 66 Augment Bone Graft 66 Investigational Device Exemption IDE 65 Marketing Authorization Application 64 Marketing Authorization Application MAA 64 exemption IDE 63 Humanitarian Device Exemption 63 Biologics License Application BLA 62 Pivotal Trial 61 Biologics License Application 61 application sNDA 60 IND submission 60 Omigard 59 FDA Accepts 59 New Drug Application 59 Complete Response 58 BLA submission 58 CORTOSS 58 Pivotal Phase III 58 Investigational 58 sBLA 57 k clearance 57 Surgical Adhesive 57 FDA approvable letter 57 FDA Approval 57 Marketing Authorization 57 Phase III Clinical Trial 56 Clinical Trial Application 56 FIRAZYR 56 sNDA 56 Bone Graft 55 alvimopan 55 Drug Application 55 Orphan Drug status 55 MONOVISC 55 supplemental Biologics License Application 55 FDA Clearance 54 LightTouch 54 alogliptin 54 CE Marked 54 postherpetic neuralgia PHN 54 GEM #S 54 USFDA approval 54 MitraClip R 54 investigational 54 pseudobulbar affect PBA 54 Mutual Recognition Procedure 54 Completes Enrollment 54 Panzem R 54 Fast Track Designation 54 Zelrix 54 k Clearance 54 phase IIb clinical 54 pancreatic insufficiency 53 BEMA TM Fentanyl 53 Clinical Study 53 Orphan Drug Status 53 Symphony tCGM System 53 Phase III pivotal 53 Neo Urinary Conduit 53 Fast Track designation 53 submitted Biologics License 53 Phase III clinical trials 52 phase IIa 52 injection USP 52 Receives CE 52 Pivotal Phase 52 VIAject 52 INDs 52 Patient Enrollment 52 OFIRMEV 52 Thrombin 52 Phase IIa trial 52 Tyvaso 52 QNEXA 52 Clevudine 52 Phase 2a clinical 52 CE Marking 52 orphan designation 52 mTOR inhibitor 52 Rhucin ® 51 liprotamase 51 PRISTIQ 51 Icatibant 51 Pirfenidone 51 NDA submission 51 received CE Marking 51 Complete Response letter 51 Phase 2b study 51 Telavancin 51 New Drug IND 51 Safe GRAS 51 Generic Version 51 PREOS 51 topical gel 51 dalbavancin 51 Clinical Trial Results 51 Abstral 51 Extended Release 51 SFDA approval