Related by context. Frequent words. (Click for all words.) 58 Investigational Device Exemption 54 Receives CE 54 k Clearance 51 FIRAZYR 51 Orphan Drug status 51 Complies 51 CE Marking 50 Pivotal Phase III 50 FDA Clearance 50 Orphan Drug designation 49 Phase III Clinical Trial 49 FDA Approval 48 Final Approval 48 orphan designation 48 Fast Track Designation 48 Orphan Drug Status 48 Scientific Advice 47 Marketing Authorization 46 Successful Completion 46 Phase III Trial 46 Mutual Recognition Procedure 46 Issues Statement Regarding 46 Receives Positive 46 supplemental Biologics License Application 46 Orphan Drug Designation 46 Supplemental Type 46 Orphan Medicinal Product 46 k clearance 46 Regulatory Approval 45 FDA Approves 45 Preliminary Approval 45 Marketing Authorization Application 45 Cervical Cancer Vaccine 44 Receives Approval 44 Panel Backs 43 Rehearing 43 Approval Process 43 Biologics License Application 42 Waiting Period 42 Approvable Letter 42 Continued Listing 42 ISO Certification 42 Proposed Changes 41 Shareholder Approval 41 sBLA 41 Fast Track designation 41 Enacts 41 Ceftobiprole 41 Preliminary Injunction 41 Welfare MHLW 41 APPROVAL 41 Panel Approves 41 Recieves 41 Ratifies 40 Modifies 40 Type Approval 40 Swissmedic 40 Long Awaited 40 Submits 39 Approval 39 European Medicines Evaluation 39 Designations 39 Moves Forward 39 ISO #:# Certification [002] 39 Preemption 39 Rhucin ® 39 Gestiva 39 pediatric exclusivity 39 Drug Application 39 Priority Review 38 Panel Recommends 38 orphan drug 38 Panel Votes 38 CHMP opinion 38 Rulemaking 38 Approves 38 Gets Approval 38 Strikes Down 38 Jobless Benefits 37 disinterested shareholder 37 Clears Way 37 silicone gel filled 37 Approved 37 taliglucerase alfa 37 Clolar 37 requisite consents 37 Panel Urges 37 Deadline Approaches 37 customary regulatory approvals 36 Authorization 36 Lawmakers Approve 36 Reorganization Plan 36 GRAS status 36 Delist 36 Nears Completion 36 Extends Deadline 35 Moves Ahead 35 Therapeutic Products 35 Revokes 35 Authorizes 35 Authorizations