Related by context. Frequent words. (Click for all words.) 50 Orphan Drug status 50 Fast Track Designation 49 Marketing Authorization Application 49 orphan designation 49 Marketing Authorization 49 Orphan Drug designation 47 Vasovist 47 Regulatory Approval 45 Final Approval 45 Preliminary Approval 44 European Medicines Evaluation 43 taliglucerase alfa 42 Orphan Drug Designation 42 sBLA 42 Scientific Advice 42 Swissmedic 42 Drug Application 42 Clolar 41 Biologics License Application 41 pediatric exclusivity 41 CHMP opinion 41 Rhucin ® 41 CE Marking 41 SFDA approval 40 Welfare MHLW 40 BENLYSTA 40 k clearance 40 Esbriet 39 Fast Track designation 39 Shareholder Approval 38 Priority Review 38 India DCGI 38 Promacta 38 Rate Decision 37 ISO Certification 37 Therapeutic Products 37 Authorization 37 Drug Administration USFDA 36 Gestiva 36 requisite regulatory approvals 36 Approval 35 regulatory approval 35 orphan drug 35 regulatory clearances 35 Approvable Letter 35 GMP certification 34 APPROVAL 33 silicone gel filled 33 Approvals 33 Supplemental Type 33 stockholder approvals 33 GRAS status 33 Special Use Permit 33 JZP 6 33 Authorizations 32 Authorizes 32 Preliminary Injunction 32 authorization 32 approval 32 regulatory authorizations 32 CFR § #.# [007] 32 Store Shelves 32 ISO #:# certification [001] 31 applicable regulatory approvals 31 regulatory approvals 31 stockholder approval 31 authorizations 31 requisite approvals 31 constitutional amendment authorizing 30 exclusivity periods 30 governmental approvals 30 Game Consoles 30 Permit 30 Consolidated Appropriations 30 antitrust clearance 30 preliminary plat approval 30 Approve 30 Designation 29 APPROVED 29 Approved 29 necessary regulatory approvals 29 Movie Theaters 29 approved 29 requisite consents 29 submittal 29 Retail Outlets 29 Authorisation 29 conditionally approved 29 disinterested shareholder 29 Finalization 29 Conditional Use Permit 29 Environmental Impact Study 28 NPDES permit 28 approvals 28 customary regulatory approvals 28 Clearance 28 Canister 28 grandstand gates 28 shareholder approvals 27 Personal Identification Number 27 Liveblog