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The Competitive Status of the U.S. Pharmaceutical Industry

The Competitive Status of the U.S. Pharmaceutical Industry

The Influences of Technology in Determining International Industrial Competitive Advantage

  • Publisher: National Academies Press
  • ISBN: 9780309033961
  • eISBN Pdf: 9780309572033
  • Place of publication:  United States
  • Year of digital publication: 1983
  • Month: January
  • Pages: 115
  • Language: English
  • 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

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  • Loan duration: 21 days
  • Format: PDF

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