Related by context. Frequent words. (Click for all words.) 59 BLA submission 57 orphan designation 56 Marketing Authorization Application 56 IND submission 55 ATryn ® 55 FIRAZYR 55 Investigational Device Exemption 55 Complete Response 55 Orphan Drug status 55 Phase III Clinical Trial 54 Orphan Drug Status 54 Biologics License Application 54 Orphan Drug designation 54 Marketing Authorization 54 Rhucin ® 54 QbD 54 Pivotal Phase III 53 Orphan Drug Designation 53 Biologics License Application BLA 53 ROTATEQ 52 Fast Track Designation 52 Exelbine 52 Scientific Advice 51 taliglucerase alfa 51 Marketing Authorization Application MAA 51 Ceftobiprole 51 Mutual Recognition Procedure 51 GRAS status 51 ONSOLIS 50 BENLYSTA 50 Fast Track designation 50 Replagal 50 CHMP opinion 50 liprotamase 50 ISO Certification 49 ZOSTAVAX 49 pharmacoeconomic 49 Vasovist 49 Phase III Trial 49 orphan medicinal product 49 Mitigation Strategy REMS 49 CE Marking 49 Cethrin 49 Priority Review 48 pediatric exclusivity 48 eCTD 48 SUMAVEL DosePro 48 Zactima 48 sBLA 48 INDs 48 PROPEL 48 Loramyc ® 48 Notified Body 48 Testim 48 CHMP 48 Promacta 48 Swissmedic 48 FDA Accepts 48 Orphan Drug 47 PREZISTA 47 European Medicines Evaluation 47 FDA approvable letter 47 Omigard 47 bioequivalence 47 Positive Opinion 47 REMS 47 GEM #S 47 Market Approval PMA 47 Orphan Medicinal Product 47 Drug Application 47 DP b# 47 supplemental Biologics License Application 47 Hatch Waxman 46 Medicinal Products EMEA 46 Afluria 46 biogeneric 46 Bevacizumab 46 Hatch Waxman Act 46 Esbriet 46 Tyverb 46 ELAPRASE 46 mTOR inhibitor 45 StaphVAX 45 maraviroc 45 Approvable Letter 45 ONTAK 45 Patient Assistance Program 45 URAC accreditation 45 Oxandrin 45 MBP# [001] 45 clinical trials 45 ComfortScan system 45 Regulatory Approval 45 Bioxel 44 clinical 44 THELIN 44 Clolar 44 Qutenza 44 Pharmacopeia USP 44 approvability 44 Rimonabant