LEADER 04502nam 2200625Ia 450 001 9910817036303321 005 20200520144314.0 010 $a1-280-24696-0 010 $a9786610246960 010 $a0-309-57203-7 010 $a0-585-21783-1 035 $a(CKB)111004366656318 035 $a(OCoLC)607691872 035 $a(CaPaEBR)ebrary10056826 035 $a(SSID)ssj0000126553 035 $a(PQKBManifestationID)11137057 035 $a(PQKBTitleCode)TC0000126553 035 $a(PQKBWorkID)10046478 035 $a(PQKB)10027455 035 $a(MiAaPQ)EBC3376552 035 $a(EXLCZ)99111004366656318 100 $a20010215d1983 uy 0 101 0 $aeng 135 $aurcnu|||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 14$aThe competitive status of the U.S. pharmaceutical industry $ethe influences of technology in determining international industrial competitive advantage /$fprepared by the Pharmaceutical Panel Committee on Technology and International Economic and Trade Issues, Office of the Foreign Secretary National Academy of Engineering, Commission on Engineering and Technical Systems National Research Council ; Charles C. Edwards, chairman ; Lacy Glenn Thomas, rapporteur 205 $a1st ed. 210 $aWashington, D.C. ;$a[Great Britain] $cNational Academy Press$d1983 215 $a1 online resource (114 p.) 300 $aBibliographic Level Mode of Issuance: Monograph 311 $a0-309-03396-9 320 $aIncludes bibliographical references and index. 327 $aThe Competitive Status of the U.S. Pharmaceutical Industry -- Copyright -- Preface -- Contents -- Summary -- FINDINGS ON THE U.S. COMPETITIVE POSITION -- DETERMINANTS OF NATIONAL PHARMACEUTICAL COMPETITIVE ADVANTAGE -- OPTIONS FOR AMERICAN POLICY -- Trade Options -- Domestic Economic Options -- Regulatory Options -- 1 Overview of U.S. Pharmaceutical Industry -- EMERGENCE OF THE MODERN PHARMACEUTICAL INDUSTRY -- NATURE OF PHARMACEUTICAL COMPETITION -- BENEFITS AND RISKS OF TECHNICAL CHANGE -- OVERVIEW AND LIMITATIONS OF THIS STUDY -- NOTES -- 2 Competitive Position of the U.S. Pharmaceutical Industry -- RESEARCH -- INNOVATION -- PRODUCTION -- SALES -- STRUCTURE -- TRADE -- SUMMARY -- NOTES -- 3 Determinants of National Pharmaceutical Competitive Advantage -- LABOR COSTS -- MARKET GROWTH -- NATIONAL SCIENTIFIC CAPACITY -- GENERAL RELATIVE DECLINE OF U.S. INDUSTRY -- INDUSTRIAL POLICY: REGULATION -- Greater Use of Expert Committees -- Greater Acceptance of Foreign Data -- Less Politicization of Drug Approval Process -- Greater Cooperation between Regulators and Industry -- INDUSTRIAL POLICY: TAXATION -- INDUSTRIAL POLICY: TRADE -- SUMMARY -- NOTES -- 4 New Developments Affecting the Industry -- SCIENTIFIC ADVANCES -- JAPANESE DEVELOPMENTS -- NOTES -- 5 Options for American Industrial Policy -- TRADE OPTIONS -- DOMESTIC ECONOMIC OPTIONS -- REGULATORY OPTIONS -- The IND Process -- Early Clinical Research -- Objectives of Investigational Drug Regulation -- Clinical Development Studies -- Preclearance of Clinical Research -- The NDA Process -- Application of the Standards for Drug Approval -- The NDA Submission and Its Review -- Utilization of Outside Expert Advice -- Application of the Standards for Drug Approval -- FDA Management -- Resources for the New Drug Review Process -- Improving Interactions with Industry. 327 $aTracking the Review Process to Ensure Timeliness -- Conflict of Interest and Expert Advisers -- Improving Interactions with Industry -- NOTES -- 6 Biographical Sketches -- Index. 606 $aPharmaceutical industry$xTechnological innovations$zUnited States 606 $aPharmaceutical industry$zUnited States 606 $aCompetition$zUnited States 606 $aDrugs$zUnited States$xMarketing 615 0$aPharmaceutical industry$xTechnological innovations 615 0$aPharmaceutical industry 615 0$aCompetition 615 0$aDrugs$xMarketing. 676 $a338.4761510973 701 $aEdwards$b Charles C$0308659 712 02$aCommission on Engineering and Technical Systems 712 02$aCommittee on Technology and International Economic and Trade Issues of the Office of the Foreign Secretary 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910817036303321 996 $aThe competitive status of the U.S. pharmaceutical industry$94203398 997 $aUNINA