Related by context. Frequent words. (Click for all words.) 48 Counter OTC 46 Swissmedic 44 Ceftobiprole 43 regulatory 41 USFDA 40 FDA 40 Mitigation Strategy REMS 40 Marketing Authorization Application 39 orphan designation 39 Regulatory 39 European Medicines Evaluation 38 biogeneric 37 Replagal 36 PDUFA 34 pharmacovigilance 34 regulated 34 regulatory framework 34 Dietary supplements 33 GMPs 33 Surveillance du Secteur 33 eCTD 33 biosimilars 32 regulatory frameworks 31 generic biologics 31 END FOOTNOTE 31 CBER 31 requisite approvals 30 Aminopterin 30 prescribed 30 biogenerics 30 Autorite des Marches Financiers 30 regulatory approval 30 metabolised 29 Drug Administration 29 legislatively mandated 29 Codex Alimentarius 29 BHCs 29 marketed 29 Prudential Regulatory Authority 28 jurisdictions 28 Regulated 28 metabolized 28 approvability 27 approvals 27 regulators 27 Hatch Waxman 27 accounting pronouncements 27 regulator 27 Regulatory Agencies 27 regulatory approvals 27 oversight 27 adverse determinations 26 rulemakings 26 #/#/EC [002] 26 Regulates 26 compliances 26 rulemaking 25 Regulator 25 unregulated 25 nonregulated operations 25 Bermuda Monetary 25 Regulate 24 loosely regulated 24 necessary regulatory approvals 24 Securities Commissions IOSCO 24 regulations 24 licensure 24 tightly regulated 24 Regulation 24 administrated 24 Regulatory Authority 24 uncontrolled 24 regulating 24 liberalized 24 regulation 23 governmentally 23 deregulated 23 equitised 23 Mifid 23 Advisers Act 23 regulates 23 legalized 23 prudential regulation 23 Reg NMS 23 customary regulatory approvals 23 ratemaking 23 governmental 23 unregulated derivatives 23 FSA 23 Hatch Waxman Act 23 clearinghouses 23 federally regulated 23 postmarket 23 IOSCO 23 largely unregulated 22 stockholder approvals 22 strictly regulated 22 regulative 22 regulatory compliance 22 prudential supervision 22 OSFI