Related by context. Frequent words. (Click for all words.) 88 Drug Administration 79 FDA 73 Drug Administration USFDA 62 Drug Administration SFDA 61 USFDA 57 Safety Authority EFSA 56 European Medicines Agency 56 CDRH 54 investigational 54 New Drug Application 53 Biologics License Application BLA 53 European Medicines Evaluation 53 DCGI 53 CDER 53 Trademark Office USPTO 52 Therapeutic Goods Administration 52 Investigational Device Exemption IDE 52 SFDA 51 k clearance 51 OTCQX RHHBY 51 CHMP 51 Act PDUFA 51 PDUFA date 51 Thyrogen 50 Cosmetic Act 50 PDUFA 50 Drug Application 50 sNDA 50 Biologics License Application 50 Marketing Authorization Application MAA 49 Mitigation Strategy REMS 49 Clolar 49 Swissmedic 49 Marketing Authorization 49 Horizant 49 Vasovist 49 Exalgo 49 ATryn 49 Phase III clinical 49 investigational compound 48 ONSOLIS 48 FDA reviewers 48 FDA Approval 48 Drugs Advisory 48 Complete Response letter 48 Drug Controller 48 Agriculture USDA 48 approvable letter 48 clinical trial 48 Trademark Office PTO 48 Replagal 48 NUVIGIL 48 Orphan Drug designation 48 Medicinal Products 48 Lumizyme 47 Board DSMB 47 sBLA 47 Cleviprex 47 PhosLo 47 ecallantide 47 Torisel 47 Patent Office 47 Renvela 47 Complete Response Letter 47 Prescription Drug User Fee 47 Human Use CHMP 47 VPRIV 47 FENTORA 46 ustekinumab 46 Regulatory Agency MHRA 46 pediatric exclusivity 46 FSANZ 46 alogliptin 46 Entereg 46 ATryn R 46 Seroquel XR 46 LIALDA 46 Fast Track designation 46 Phase III clinical trials 46 Inspection Service 46 Abbreviated New 46 Kuvan 46 KFDA 46 NDA submission 45 Investigational 45 intravenous formulation 45 Cinryze 45 Priority Review 45 clinical trials 45 USPTO 45 Genetic Engineering Approval 45 Afrezza 45 pivotal Phase III 45 chronic angina 45 CE Marking 45 Marketing Authorization Application 45 Warning Letter 45 injectable formulation 45 motavizumab 45 INDs 45 ANDAs