Related by context. Frequent words. (Click for all words.) 62 Research CDER 60 Biologics Evaluation 56 CDER 56 Act PDUFA date 55 Mitigation Strategy REMS 53 NOXAFIL 53 Drug Administration FDA 52 CDRH 52 Risk Evaluation 52 FDA 52 Complete Response letter 52 Complete Response 51 Drug Evaluation 51 INDs 51 Marketing Authorization Application 51 Oncology Drug 51 Cimzia R 50 Full Prescribing Information 50 Prescribing Information 50 DCGI 50 European Medicines Evaluation 49 alvimopan 49 bazedoxifene 49 Swissmedic 49 Committee GEAC 49 Complete Response Letter 49 SFDA 49 Thyrogen 49 BLA submission 49 Drug Administration USFDA 49 PDUFA date 49 ATryn R 49 Drug Application 49 Biologics License Application BLA 48 Rhucin ® 48 Investigational Device Exemption 48 BioDelivery Sciences 48 Biologics License Application 48 Ceftobiprole 48 CHMP opinion 48 prGCD 48 USFDA 48 Act PDUFA 48 IMVAMUNE R 48 Icatibant 47 Tygacil 47 Safety Authority EFSA 47 CBER 47 sBLA 47 Orphan Drug status 47 CHMP 47 therapeutic monoclonal antibodies 47 Safe GRAS 47 ISMP 47 Drug Controller 47 Marketing Authorization 47 NASDAQ BPAX 47 Mutual Recognition Procedure 47 ustekinumab 46 Drug Administration 46 NUVIGIL 46 FENTORA 46 Metabolic Drugs Advisory 46 OTCQX RHHBY 46 Prescription Drug User Fee 46 Onsolis 46 Topiramate 46 pseudobulbar affect PBA 46 pharmacovigilance 46 ICMR 46 Avastin bevacizumab 45 Research Protections 45 Marketing Authorization Application MAA 45 Pirfenidone 45 Torisel 45 PDUFA 45 ONSOLIS 45 European Medicines Agency 45 Myobloc 45 http:/www.fda.gov 45 CrossRef Web 45 sNDA 45 Ampligen 45 Lumizyme 45 Citizen Petition 45 PUBMED 45 Radiological Health 45 Investigational 45 Divine Worship 45 Pharmacovigilance 45 Genetic Engineering Approval 45 X Excite 45 UM Comprehensive Cancer 45 bioequivalence 45 Orphan Drug designation 45 orphan medicinal product 45 Orphan Drug 45 Exalgo 45 PhosLo 45 GRAS status 44 EFSA