""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""
