Related by context. Frequent words. (Click for all words.) 47 Panel Rejects 46 Omigard 43 supplemental Biologics License Application 43 Panel Backs 42 exemption IDE 42 Fast Track Designation 42 Investigational Device Exemption 41 Plenaxis R 41 Panel Votes 41 Orphan Drug status 41 Approved 41 Orphan Drug Status 40 IND submission 40 Complies 40 liprotamase 40 Clinical Trial Application 40 Drug Application 40 Swissmedic 40 Marketing Authorization Application 39 Biologics License Application 39 Welfare MHLW 39 granted Fast Track 39 Rhucin ® 39 Deadline Approaching 38 BrachySil 38 Deadline nears 38 Scientific Advice 38 Medicinal Products EMEA 38 APPROVE 38 Clears Way 38 Cervical Cancer Vaccine 38 APPROVED 38 resubmits 38 taliglucerase alfa 38 Extends Deadline 38 Marketing Authorization 38 Market Approval PMA 37 Panel Recommends 37 Deadline Approaches 37 Humanitarian Device Exemption 37 Submits 37 European Medicines Evaluation 37 ComfortScan system 36 Orphan Drug designation 36 Final Approval 36 FDA approvable letter 36 Deadline Extended 36 Modifies 36 mucopolysaccharidosis VI MPS VI 36 JZP 6 36 SFDA approval 36 exclusivity periods 36 sBLA 36 Esbriet 36 FIRAZYR 36 Announces Receipt 36 Panel Urges 36 granted orphan 35 clears hurdle 35 resubmission 35 submittal 35 Priority Review 35 Panel Approves 35 Allow 35 Delays Decision 35 approved 35 Verifies 35 Receives Approval 35 CE Marking 35 Gets Approval 35 Panel OKs 35 Reconsiders 34 Fast Track designation 34 Discontinue 34 Exempts 34 Therapeutic Products 34 Solzira 34 Orphan Drug Designation 34 Groups Urge 34 assurance QA 34 Certifies 34 BENLYSTA 34 Okayed 34 Finalizes 34 Administer 34 USFDA approval 34 PROPEL trial 34 Designates 34 validation 33 Volunteers Needed 33 Expanded 33 Approvable Letter 33 Takes Steps 33 Moves Forward 33 CHMP opinion 33 confirmatory Phase 3 33 ISO Certification 33 India DCGI 33 expediting 33 orphan designation 33 Deadline Nears