The 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, rapporteur

• Record Nr.: UNINA9910817036303321
• Pubbl/distr/stampa: Washington, D.C. ; ; [Great Britain], : National Academy Press, 1983
• ISBN: 1-280-24696-0; 9786610246960; 0-309-57203-7; 0-585-21783-1
• Edizione: [1st ed.]
• Descrizione fisica: 1 online resource (114 p.)
• Altri autori (Persone): EdwardsCharles C
• Disciplina: 338.4761510973
• Soggetti: Pharmaceutical industry - Technological innovations - United States; Pharmaceutical industry - United States; Competition - United States; Drugs - United States - Marketing
• Lingua di pubblicazione: Inglese
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Note generali: Bibliographic Level Mode of Issuance: Monograph
• Nota di bibliografia: Includes bibliographical references and index.
• Nota di contenuto: 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.