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.