Related by context. Frequent words. (Click for all words.) 84 Drug Administration 79 Drug Administration FDA 66 USFDA 66 CDRH 60 FDA reviewers 58 European Medicines Agency 58 FTC 57 SFDA 56 von Eschenbach 56 PDUFA 56 FSANZ 55 Therapeutic Goods Administration 55 Galson 54 CHMP 54 FSIS 54 EFSA 54 Ketek 53 TGA 53 CPSC 53 MHRA 53 Pristiq 52 ATryn 52 Entereg 52 Medsafe 52 Serevent 51 Von Eschenbach 51 NIH 51 clinical trials 51 Fentora 51 Bydureon 51 FDA Approval 51 Exanta 50 Zelnorm 50 Glaxo 50 GSK 50 PDUFA date 50 USDA 50 clinical trial 50 BioMimetic 50 USPTO 50 liver toxicity 49 Ranexa 49 approvable letter 49 EPA 49 Safety Authority EFSA 49 Act PDUFA 49 AMAG 49 Byetta 49 Effient 49 Benlysta 49 Vivus 49 Clolar 49 Avandia 49 approvable 48 investigational 48 Cinryze 48 Contrave 48 Drug Evaluation 48 Orexigen 48 Myozyme 48 Victoza 48 Bextra 48 NDA submission 48 ANDAs 48 CFIA 48 Actemra 48 Cubicin 48 Galvus 48 REMS 48 BFAD 48 AQSIQ 48 biosimilar 48 Xarelto 48 Drug Administration SFDA 48 Tysabri 48 Sharfstein 48 Darvon 47 Complete Response Letter 47 Allergan 47 Natrecor 47 Evista 47 Xience 47 Prescription Drug User Fee 47 Regulatory Agency MHRA 47 Intrinsa 47 Provenge 47 pharmacovigilance 47 Steris 47 Encysive 47 Priority Review 47 sNDA 47 drugmakers 46 Tykerb 46 Crestor 46 nonprescription 46 bioequivalence 46 Xolair 46 Medicinal Products 46 Biogen 46 pharmaceutical 46 biogenerics