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46 Ucits IV 46 affecting Amarin 46 regula tory 46 prudential supervision 46 OraTest R 46 procyclical effects 46 Daren Bakst legal 46 prudential oversight 46 Basel III accord 46 CLERP 9 46 postmarket surveillance 45 macroprudential regulation 45 countercyclical buffers 45 prudential regulator 45 Mirko Bibic Bell 45 supervisory 45 cethromycin NDA 45 Adequately Capitalized 45 macroprudential tools 45 statutory 45 AETI SEC 45 exchanges depositories 45 ratemaking 45 Macro prudential 45 Solvency II directive 45 Lamfalussy process 44 reputational risk 44 indebtedness covenant 44 legislative 44 OTC derivatives clearing 44 oversight 44 macroprudential supervision 44 Basle II 44 Subpart E 44 Ken Engelhart 44 Cesr 44 Solvency II Directive 44 BioClinica operates 44 MIFID 44 corporate governance 44 #CFR Part 44 WDEQ Permit 44 LNG siting 44 Notified Bodies 44 biogeneric 44 authority Swissmedic 44 regulating 44 FDAs 44 F.D.A. 44 INFLUENCE GAME Govt 44 CenturyLink Qwest merger 44 cells Tregs 44 Jimi Grande 44 Shahrawat 44 Branko Terzic 44 bureaucratic 44 pulls Darvon painkiller 43 Gramm Leach Bliley GLB 43 Cfius 43 chairwoman Paula Rebstock 43 adversely affect Univest Corporation 43 promote ceftobiprole 43 Basel III norms 43 micro prudential 43 Board PMRB 43 FOXP3 + 43 FDICIA 43 Mr. Wetston 43 BCFP 43 consummating acquisitions 43 macro prudential supervision 43 FDA 43 postmarketing surveillance 43 adversely affecting Cubist 43 LDTs 43 Conseil Supérieur de l' 43 Helvea analyst Olav Zilian 43 Elmer Danenberger retired 43 bioresearch monitoring 43 regulatory compliances 43 Exelon PSEG 43 Securities Regulators CESR 43 PKC isozymes 43 obtaining regulatory approvals 43 REACH RoHS 43 FDA Accelerated Approval 43 thefinancial 43 Mifid 43 authority Gurian Sherman 43 Clinical Trials Directive 43 AML BSA 43 jurisdictional 43 derivatives clearinghouses 43 GSK Avandia 43 Autorite des Marches Financiers 43 Robert Schwaneberg covers 43 Finansinspektionen 43 Dr. Pazdur 43 acquisitions divestures 43 risks associatedwith 43 Mutual Funds Regulations 43 unnecessarily duplicative 43 QFCRA 43 CARNA 43 micro prudential supervision 43 FATCA 43 Counter OTC remedy 43 cGMPs 43 Cofeco 43 microprudential 42 LBRO 42 TMX LSE merger 42 nondepository 42 stricter emission 42 authority NMa 42 interdepartmental coordination 42 Mirko Bibic 42 NISM 42 IIROC carries 42 biogenerics 42 PWBank 42 Genetic Therapies Directorate 42 SLHCs 42 NDA BLA 42 Ferc 42 forbearance petitions 42 xxxi adverse tax 42 compliance therewith 42 Susanne Guyer Verizon 42 CLERP 42 economicconditions 42 Regadenoson 42 Accountable Care Organizations ACOs 42 FIDAC regulatory 42 SERCs 42 regulatory clearances 42 PDUFA reauthorization 42 rulemakings 42 Skrzycki 42 eCTD submission 42 Stricter regulations 42 portfolio margining 42 Sarbannes Oxley Act 42 Larosiere 42 macroprudential oversight 42 Commission BCUC 42 Zincore dated March 42 postapproval 42 FierceGovernmentIT tracks 42 federally insured depository 42 pharmacoeconomic 42 Cloakware patented layered 42 Safeguards Rule 42 comitology 42 CFRA forensic accounting 42 Ms Diplock 42 overly prescriptive 42 jurisdictional thresholds 42 MAAs 42 Lignol files 42 visitorial powers 41 Applications ANDA 41 premerger notification 41 RegNMS 41 megabanks straddling 41 Filing Statement filed 41 Dave Neslin acting 41 GxP 41 Gary Gensler chairman 41 macro prudential regulation 41 financial 41 Reputational risk 41 potency APIs 41 MHRA Medicines 41 pricing 41 SEBI IRDA 41 notifiable transaction 41 prudential 41 PCI DSS SOX 41 reregulation 41 Pharma Payor benefit 41 Public Utilities Commissions 41 Devicemakers 41 HIPAA HITECH 41 consents authorizations 41 Bombarding federal 41 Janet Trunzo 41 chairwoman Jane Diplock 41 necessary regulatory approvals 41 HSNO Act 41 Pfizer inhaled insulin 41 NRAs 41 macrofinancial 41 horizontal overlaps 41 DeRoma 41 Basel Accords 41 HAVA mandates 41 Swissmedic 41 FDAAA 41 Basel Accord 41 please visit www.innercool.com 41 BEREC 41 SOX Sarbanes Oxley 41 Prudential Regulation Authority 41 general economicconditions 41 Corporation TSX DC.A 41 Miscellaneous Fares 41 MJ Moltenbray partner 41 mutualization 41 Mofcom 41 FoxP3 41 Angelyn Frazer 41 affecting Pennichuck Corporation 41 compliances 41 FDA Deborah Autor 41 practices GMPs 41 FuelQuest solutions 41 PCA Directive 41 Orathecin 41 LOPROX R 41 RegPro 41 accounting pronouncements 41 andeconomic 41 marketconditions 41 SIFIs 41 Favrille filings 41 NERC CIP standards 41 inter jurisdictional 41 researchand 41 successfully commercialize Silenor 41 telavancin NDA 41 topdown command 41 INTUNIV TM 41 ePrivacy Directive 41 WHO prequalification 41 Exelbine NDA 41 Standards CFATS 41 Ronald Gruia principal 41 Comcast NBCU merger 41 docetaxel emulsion 41 Bioaccelerate compounds under 41 regulator APRA 41 LRRA 41 CORTOSS Bone Augmentation Material 41 andfinancial 41 Company noncontributory defined 41 deregulation 41 biosimilar medicines 41 overspending overtaxing 41 Smart Grid interoperability 40 insufficiently resourced staffed 40 CBUAE 40 Diep Tran MD 40 unconstitutional overreach 40 ISIPublisher 40 governing 40 governmental approvals 40 ZURICH AFX Novartis AG 40 Quebec Autorité des 40 Centralized Procedure 40 otherrisks 40 adjudicatory 40 cells Treg 40 MARK STODGHILL reports 40 anticompetition 40 megawatt Highwood plant 40 overregulate 40 M &A; finance 40 Sarbanes Oxley 40 Lon Leneve President 40 Plenaxis R 40 premerger 40 excessively burdensome 40 ICH GCP 40 Iusacell Celular 40 Subpart H 40 infant formula contaminant 40 impactof 40 macroprudential 40 Regulator 40 ICH guidelines 40 mergers consolidations 40 anduncertainties 40 corpo rate 40 Daren Bakst 40 mitotic checkpoint 40 miRNA therapeutics 40 ourability 40 nonbank subsidiaries 40 Competent Authorities 40 Maijoor 40 pricing pressures 40 antimonopoly 40 Quaadman 40 AquaBounty countered 40 jurisdictions 40 Consob Italy 40 Quebec Autorite des 40 postmarket studies 40 successfully commercialize Iluvien 40 chemically derived 40 antitrust 40 Systemically important 40 Beth Preiss 40 stockholder approvals 40 Christopher Libertelli 40 Introgen maintains 40 NRSRO designation 40 Contrave NDA 40 fin reg 40 OCC OTS Federal Reserve 40 Rosario Palmieri vice 40 Commissioner Jon Wellinghoff 40 Bioenvision filings 40 Commodities Authority ESCA 40 Autorité de 40 boards IRBs 40 Exelbine 40 Preotact 40 REACH Regulation 40 Exelon NRG 40 AIFM Directive 40 Regulatory Excellence CHRE 40 Tom Quaadman 40 Merc CBOT 40 macro prudential 40 MHLW 40 Metformin GR 40 Securities andExchange Commission 40 uveitis Crohn Disease 40 Boiler MACT 40 Biophan patent 40 David Kaut telecom 40 prudentially regulated 40 HCT Ps 40 Standards GIPS 40 FFIEC Guidance 40 quasi judicial 40 Transparency Directive 40 spokeswoman Lenore Gelb 40 institutionalize bailouts 40 LSE TMX deal 40 Ethiopis Tafara 40 TranSwitch indebtedness 40 ILC charters 40 Regulation 40 adopting IFRS 40 chairwoman Mary Schapiro 40 deregulatory 40 generic Copaxone 40 Alan Beller 40 histamine dihydrochloride 40 Rule 2a 7 40 Commission CNBV 40 unduly distort 40 DUO1 40 statuatory 40 ComCom 40 PbR 40 Interpretative Communication 39 RAPIDGate Program contains 39 Waratah Coal filings 39 Hatch Waxman Amendments 39 Consolidated Supervised Entities 39 Novartis Gilenia 39 spokesman Kevin Mukri 39 novel therapeutic modality 39 technological 39 re domiciling 39 ISVAP 39 ATA SRO 39 PROLOR filings 39 AFSSAPS 39 Patent expiries 39 withrespect 39 reregulating 39 macroenvironment 39 eSubmissions 39 allergen labeling 39 uplist 39 Therapeutic Goods Administration TGA 39 BSA AML compliance 39 Vibativ 39 ICH GCP standards 39 biosimilar versions 39 By Charlie Caroe 39 Drugmaker Roche 39 synthetic fertilizers hormones 39 legal proceedings xxi 39 nonregulatory 39 Biovail Melnyk 39 Hatch Waxman 39 NASD Rule 39 overburdensome 39 mergers 39 Sarbanes Oxley SOX Gramm 39 FSRA 39 Marketing Authorization Applications 39 respond flexibly 39 confi dential 39 USFDA 39 TWYNSTA ® 39 ANDA filings 39 siting permitting 39 trans sectoral 39 Rosario Tijeras 39 wazoo McGloughlin 39 Karim Samii president 39 ANATEL 39 Fanandakis 39 David Marchick 39 generic biologic 39 intercarrier compensation payments 39 auditor attestation 39 AMP demerger 39 Pre IND 39 exclusivities 39 EFTA Surveillance Authority 39 AdvaMed lobbied 39 antirust 39 agency Sernageomin 39 cardiac myosin actin 39 Unitholder liability 39 Self Regulatory Organization 39 NerPharMa 39 redomiciling 39 Reinsurance Directive 39 insured depositories 39 Therapeutic Products Swissmedic 39 APF# NDA 39 Colleague infusion pump 39 regulate 39 c myb 39 shorezone ordinances 39 compulsory insurances 39 Schering-Plough/Merck 39 IND CTA 39 Ms. Schapiro 39 allegations Rydze violated 39 orlistat marketed 39 fleeting expletive policy 39 Services LACORS 39 wagering ceasing 39 IFRS changeover 39 Ms Oteh 39 eCTD 39 CFTC Gensler 39 NPDES permitting 39 ourbusiness 39 insured depository 39 DYNACIN R Tablets 39 FSFR 39 Analyte Specific Reagent 39 FERC 39 generic Lovenox 39 FERC MPSC NRC 39 streamlined legally defensible 39 OFCs 39 CBER 39 impact assessments EIAs 39 BugOil R 39 QSound periodic reports 39 postmarket 39 CenturyLink Qwest 39 ERGEG 39 Drug Administration 39 FSOC 39 SEFs 39 MDUFMA 39 ERISA pre emption 39 AudioCodes filings 39 fiat monetary 39 Chief Executive Cameron Clyne 39 Dodd Frank 39 divestitures 39 specific messenger RNAs 39 Congress reshaped recessive 39 APRA regulated 39 SCENARIOS Possible 39 Autorité 39 Andreas Pohlmann 39 QFC Regulatory Authority 39 DIFs 39 CVS Longs 39 RRGs 39 equivalent Reglan 39 directive Ionides 39 unnecessarily burdensome 39 DC Bead 39 superagency 39 requisite approvals 39 OCABR 39 grandfathering provisions 39 David Tittsworth 39 unduly constrain 39 David Janazzo 39 Regulatory Affairs 39 macroeconomic 39 Merck Arcoxia 39 Commissioner Kathleen Abernathy 38 COMAH 38 MiFID 38 fusion enhancers 38 ADVEXIN clinical 38 MEPACT 38 de Larosiere 38 regulating GHGs 38 FINRA NASD 38 legislatively mandated 38 Exon Florio 38 coal combustion byproducts 38 requirements xxii 38 scammers preying 38 UDAP 38 inspectional observations 38 Nick Fanandakis 38 NGER Act 38 exemptive 38 Hogan Hartson LLP 38 Rasilez HCT 38 BRILINTA 38 title taxation sociopolitical 38 Chairman Jane Diplock 38 FSDC 38 HIPAA Gramm Leach Bliley 38 carveouts 38 GPhC 38 BGE ratepayers 38 sirtuin modulators 38 Board OEB 38 ANSI T#.# 38 nonregulated operations 38 unarranged overdraft charges 38 ANVISA 38 Zodwa Ntuli 38 William Ruberry spokesman 38 Administration NCUA 38 contingent guaranties 38 Erik Sirri 38 Alitretinoin 38 FSA Sants 38 Alasdair Breckenridge 38 antibacterial therapeutics 38 Cidra plant 38 iDMS 38 govermental 38 HEALTH PLAN WEEK 38 MIMPS 38 Periostat R 38 overregulation 38 Ambulatory EHR certification 38 PRIPs 38 Issuer Bid Circular 38 MNEs 38 Dr. Rhona Applebaum 38 facilitatory 38 Audiovisuel CSA 38 QbD 38 predecisional 38 FRRP 38 cripple appraiser 38 integrated synchronous buck 38 approvable letters 38 E.ON Endesa 38 Antonio Catricala 38 FINANCIAL SERVICES AUTHORITY 38 GEM #S ® 38 unmetabolized medicine 38 Marilyn Crockett 38 Registration Evaluation Authorization 38 FFIEC guidance 38 Zelnorm Zelmac 38 xxvi introduction 38 Sarbanes Oxley Basel 38 Advisers Act 38 antibribery laws 38 eCTD submissions 38 MEMO/#/# [002] 38 Ceftobiprole 38 Hassoun waffled greatly 38 orphan medicinal 38 forborne 38 arenot limited 38 quasi judicial powers 38 Civil Contingencies Bill 38 Ruth Y. Goldway 38 regualtions 38 Immtech clinical trials 38 FSA 38 biopreservation media products 38 WHIP FIP BABIP 38 PDUFA 38 oversee nonbank 38 Azuma Ohno 38 permitting timelines 38 regula tion 38 spokesman Neal McGarity 38 Antitrust Improvement 38 Blowouts onshore Fear 38 FASB IASB 38 Robert Yakushi Nissan 38 ACTONEL 38 FCC PTCRB 38 Thyroid hormones 38 SGX ASX 38 mega mergers 38 TSX DC.PR.A TSX 38 alogliptin NDA 38 Ceiops 38 leglislation 38 GMO cultivation 38 GLB Act 38 watchdog Rostekhnadzor 38 Pari Mutuel Agency 38 pharmacovigilance 38 Stephanie Dhue reports 38 crossholding 38 NHS Commissioning Board 38 Securities Commissions IOSCO 38 ESCRO committee 38 ICH Q8 38 regulates Fannie 38 torsemide ER 38 xv licensing 38 insufficiently rigorous 38 alpha7 NNR 38 Avoid jalapenos 38 RIGScan CR 38 quasijudicial 38 theeconomic 38 SERFF 38 Progenta TM 38 extra territoriality 38 maker Barr Pharmaceuticals 38 devicemakers 38 NIH grantees 38 NASD FINRA 38 By Giles Mole 38 pharmaceuticals nutraceuticals specialty 38 offuture 38 John Kammeyer TVA 38 Fanapt ™ 38 overly proscriptive 38 Waste Incineration Directive 38 Review RDR 38 approvability 38 Dacogen injection 38 AquAdvantage Salmon 38 Marketing Authorizations 38 Capital Requirements Directive 38 Annuity Transactions Model 38 FERC NERC 38 MAA submission 38 institutions FSIs 38 Tactical Armored 38 deCODE filings 38 procyclicality 38 deregulated 38 NAB AXA 38 regulator Oftel 38 stringent emission 38 intercarrier compensation 38 Anti Monopoly Law 38 legally enforceable undertakings 38 Afri Can periodic 38 MCCSR 38 SemGroup LP SemGroup 38 post transcriptional 38 tightly regulated 38 ARLP Partnership 38 orphan designation 38 economywide 38 non selective NSAIDs 38 Marketing Authorization Application 38 flu vaccine Fluarix 38 deregulates 38 CPSS IOSCO 38 GMP GLP 38 Mitigation Strategy REMS 38 AML CFT 38 FRS FinancialAnalytics 38 adverse determinations 38 ruxolitinib 38 XENAZINE 38 requisite stockholder 38 Regulatory Agencies 38 Sally Katzen 38 cystic fibrosis transmembrane 38 requiring Asthmatx 38 Ficora 38 Sarbanes Oxley Gramm Leach 38 antimoney laundering 38 Ms Rebstock 38 biomarker validation 38 MethyPatch 38 passporting 38 bovine TB eradication 38 END FOOTNOTE 38 Takeover Directive 38 Replagal 38 ITU ETSI 38 Flutiform ™ 38 Eugene Kimmelman deputy 38 FINRA Rule 38 Contract Certainty 38 Marc Lackritz president 38 Nondisclosure agreements 37 implemen tation 37 miconazole MBT 37 Tang Shuangning vice 37 Authority ESMA 37 Enrico Dallavecchia 37 EPBC 37 regulator Cofetel 37 Reuters EcoWin 37 APDN SEC 37 By Emily Benammar 37 Utility MACT 37 Regulatory Authority 37 Mediation Directive 37 obesity pill Acomplia 37 Ucis 37 financial institutions SIFIs 37 cardiac sarcomere highly 37 bio similars 37 prudential regulations 37 GLP GMP 37 unbundling 37 intellectualproperty 37 Laboratory Practices GLP 37 antiinfective 37 Sena Fitzmaurice 37 FHCs 37 blood thinner prasugrel 37 OSFI 37 Gaddy alerted 37 market PolyHeme commercially 37 securities depositories 37 filthy foul smelling 37 Joulferon 37 Western Keltic shareholders 37 eMDR 37 ADVEXIN therapy 37 Analyst Rebecca Arbogast 37 PDEIS 37 systemically risky 37 Excluding acquisitions divestitures 37 TranSwitch filings 37 CBBCBB 37 Mattiuz 37 filingswith 37 work stoppages quarantines 37 Shire ADHD 37 EHT AGN 37 certain mapping catheters 37 CONSOB 37 spokesman Don Vecchiarello 37 FFIEC guidelines 37 Chemicals REACH 37 REMOXY NDA 37 Toxics Rule 37 Anthony Belchambers chief 37 Freshfields Bruckhaus Deringer LLP 37 Glorikian 37 Sarbox 37 Hanaa Adwar 37 Associations EFPIA 37 Cobalt Pharmaceuticals 37 biosimilars 37 ICPC EFCC 37 Interagency Guidance 37 Organization NRSRO 37 MMSEA 37 Hfq 37 unregulated 37 SUEZ Environnement 37 BLA filing 37 Afri Can periodic filings 37 systemic 37 legis lation 37 BASEL II 37 Alice H. Hedt 37 org suffix 37 Codex Alimentarius 37 SOX GLBA 37 corporate 37 Mr. Dalfen 37 egX Canada 37 EU Directive #/#/EC 37 Comision Federal de Competencia 37 eDisclosure 37 allocative 37 IHE Integrating 37 Langes + 37 shareowner 37 suffice Batson 37 Secure Computing periodic 37 Retransmission consent 37 Nebido 37 payer reimbursement 37 untangle bureaucratic 37 DMFs 37 ISTODAX 37 EGRIFTA TM 37 spokesman Herb Perone 37 CFR #.# [008] 37 subsidiarisation 37 OTC ZEGERID 37 OraTest 37 mortage backed 37 GHG emitting 37 Reg NMS 37 Autorite 37 Vedanta Cairn deal 37 La.Code Crim.P. art 37 franchisor franchisee relationship 37 MIIs 37 thetransaction 37 HIPAA Privacy Rule 37 Authority URCA 37 Fully conversant 37 andindustry 37 CCPs 37 Cialis dosage 37 offinancial 37 lender consents 37 coal slurry ponds 37 devices incorporating Signalife 37 Menaflex implant 37 balsalazide tablet 37 European Medicines Evaluation 37 securityholder approval 37 MSRB Rule G 37 Fast Track designations 37 nonprescription NSAIDs 37 Myron Brilliant senior 37 market dynamic revaluating 37 smog forming ozone 37 Peter Montagnon director 37 regulates 37 Cabotage Law 37 PUHCA 37 PCI HIPAA 37 Stonewall BDL 37 inancial 37 Zeneus 37 Helena Ostman spokeswoman 37 Enhance Biotech 37 pill Qnexa 37 Troxatyl TM 37 PEFs 37 Regulatory Structure 37 designated cethromycin 37 Scoping Plan 37 Code Section #A 37 Redlands Emotions Anonymous 37 NOPR 37 NASD 37 Institution Supervisory 37 Credit raters 37 applicable regulatory approvals 37 CAMELS rating 37 SWX BSLN 37 Exchange Commission 37 Trevor Mundel 37 generic biologics 37 licensure 37 Rule 2a 37 Abbas Araghchi deputy 37 authority FINMA 37 pharmaceutical excipients 37 standardization 37 Pending regulatory approvals 37 statutory clearances 37 Microfinance Institutions Network MFIN 37 EquaGen 37 BioGlue ® 37 Bermuda Monetary 37 Hatch Waxman Act 37 investor QFII 37 Ecopetrol SA Ecopetrol 37 liquidity buffers 37 EOBR mandate 37 Non tariff barriers 37 Taseko commented 37 Bundeskartellamt 37 harmonization 37 Dr. Reza Barazesh 37 Kwalwasser 37 scale CGMP 37 vascular constriction 37 GHG permitting 37 RCW #.#.# [001] 37 biologics FOBs 37 PolyHeme ® 37 customary regulatory approvals 37 Genetic Manipulation 37 Abbokinase R 37 spokesman Darin Barter 37 Laboratory Practice GLP 37 IADSA 37 regulator OFWAT 37 Decree #/#/ND-CP [001] 37 FSA Handbook 37 #L Sterilizer 37 Act FDAAA 37 unduly onerous 37 Cipfa 37 AEEG 37 Premarket Approval 37 xxi 37 trading symbol GCKO 37 EIOPA 37 EvaMist NDA submission 37 Antitrust 37 premarket notification 37 Candente relies upon 37 Mr. von Finckenstein 37 adversely affect Linktone 37 Biologic License Application BLA 37 HSCRC 37 N Rangachary 37 Enhesa 37 Voraxaze 37 Postcomm 37 GMPs 37 Hector Sants FSA 37 quasipublic 37 territory Schaaphok 37 chair Paula Rebstock 37 Acurox r Tablets 37 distortive effects 37 Primera Bioscience 37 hoFH 37 Midterm politicking hovers 37 Postmarket 37 Finra 37 v Dot VN 37 Sudha Narayanamurthy 37 Bayer Onyx 37 macro economic 37 gene spliced foods 37 Jean St Gelais 37 Telus BCE 37 Cindy Fornelli 37 Pharmacopeia USP 37 IOSCO 37 IORP 37 pathways microRNAs 37 Danier continuous 37 regulatory arbitrage 37 catalytic converters leaded gasoline