Related by context. Frequent words. (Click for all words.) 52 Drugs Controller 52 pediatric exclusivity 51 postmarket 51 FDA 51 FIFRA 51 BrachySil 50 clinical trials 50 QbD 50 NeutroSpec 50 CORTOSS 50 PREOS 50 Thyrogen 50 Mitigation Strategy REMS 49 bioequivalence studies 49 Plenaxis R 49 bioequivalence 49 India DCGI 49 Mylotarg 48 ISTODAX 48 Augment Bone Graft 48 Research CDER 48 JANUMET 48 Emend 48 CGMP 47 promulgate regulations 47 Drug Administration 47 IPLEX 47 Amgen Aranesp 47 Investigational Device Exemption 47 Nortel remedial 47 Medicinal Products EMEA 47 PROPEL trial 47 microbiological testing 47 Regranex 47 Afluria 47 Federal Insecticide Fungicide 47 Protopic 47 Telavancin 46 Vandetanib 46 Avastin bevacizumab 46 Clolar 46 BLA submission 46 ATryn R 46 Icatibant 46 alvimopan 46 Bepreve 46 Relistor 46 FOSRENOL R 46 ATryn ® 46 dalbavancin 46 Drug Administration FDA 46 Humanitarian Device Exemption 45 clinical trial 45 supplemental Biologics License Application 45 Afresa 45 DCGI 45 PRISTIQ 45 LIALDA 45 Marketing Authorization Application 45 calcitonin 45 Boxed Warning 45 Rosiglitazone 45 PhosLo 45 FIRAZYR 45 FCPA compliance 45 XEOMIN 45 renal toxicity 45 ustekinumab 45 liprotamase 45 Invirase 45 NOXAFIL 45 pancreatic enzyme 45 bazedoxifene 45 Bioterrorism Act 45 Pirfenidone 45 GRAS status 45 postmarketing 45 Cimzia R 45 Hycamtin 45 Dr. Jeffrey Shuren 45 alogliptin 45 surrogate endpoint 45 Tyvaso 44 Exelbine 44 CDRH 44 NUVIGIL 44 Tygacil 44 pharmacoeconomic 44 MelaFind 44 Digoxin 44 Saphris 44 Foradil 44 Omigard 44 Promacta 44 Zolinza 44 oral anticoagulant 44 approvability 44 Market Approval PMA 44 THELIN 44 phosphate binders 44 ProAmatine