04502nam 2200625Ia 450 991081703630332120200520144314.01-280-24696-097866102469600-309-57203-70-585-21783-1(CKB)111004366656318(OCoLC)607691872(CaPaEBR)ebrary10056826(SSID)ssj0000126553(PQKBManifestationID)11137057(PQKBTitleCode)TC0000126553(PQKBWorkID)10046478(PQKB)10027455(MiAaPQ)EBC3376552(EXLCZ)9911100436665631820010215d1983 uy 0engurcnu||||||||txtrdacontentcrdamediacrrdacarrierThe competitive status of the U.S. pharmaceutical industry the influences of technology in determining international industrial competitive advantage /prepared 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, rapporteur1st ed.Washington, D.C. ;[Great Britain] National Academy Press19831 online resource (114 p.)Bibliographic Level Mode of Issuance: Monograph0-309-03396-9 Includes bibliographical references and index.The 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.Tracking the Review Process to Ensure Timeliness -- Conflict of Interest and Expert Advisers -- Improving Interactions with Industry -- NOTES -- 6 Biographical Sketches -- Index.Pharmaceutical industryTechnological innovationsUnited StatesPharmaceutical industryUnited StatesCompetitionUnited StatesDrugsUnited StatesMarketingPharmaceutical industryTechnological innovationsPharmaceutical industryCompetitionDrugsMarketing.338.4761510973Edwards Charles C308659Commission on Engineering and Technical SystemsCommittee on Technology and International Economic and Trade Issues of the Office of the Foreign SecretaryMiAaPQMiAaPQMiAaPQBOOK9910817036303321The competitive status of the U.S. pharmaceutical industry4203398UNINA