Developing new contraceptives : obstacles and opportunities

Developing new contraceptives obstacles and opportunities

Detalles Bibliográficos
Autor Corporativo: Committee on Contraceptive Development (U.S.) (-)
Otros Autores: Mastroianni, Luigi (-), Donaldson, Peter J., Kane, Thomas T., 1951-
Formato: Libro electrónico
Idioma:Inglés
Publicado: Washington, D.C. : National Academy Press 1990.
Edición:1st ed
Materias:
Contraceptives > Research > United States.
Contraceptive drugs > Research > United States.
Ver en Biblioteca Universitat Ramon Llull:https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009820337706719
Tabla de Contenidos:
  • Developing New Contraceptives
  • Copyright
  • Preface
  • Acknowledgments
  • Contents
  • Executive Summary
  • THE NEED FOR NEW CONTRACEPTIVES
  • FDA REGULATION OF CONTRACEPTIVE PRODUCTS
  • PRODUCTS LIABILITY LAW AFFECTING CONTRACEPTIVES
  • CONCLUSION
  • 1 Introduction
  • ORGANIZATION
  • 2 The Need for New Contraceptives
  • CURRENT CONTRACEPTIVE USE
  • Contraceptive Practice
  • Contraceptive Effectiveness
  • POTENTIAL EFFECTS OF NEW CONTRACEPTIVES
  • Reducing Abortions
  • Contraception and Health
  • Reducing the Problems Associated with Existing Methods
  • Increasing the Coverage and Quality of Contraceptive Services
  • THE IMPORTANCE OF CONTRACEPTIVE DELIVERY
  • CONCLUSION
  • 3 The Current Status of Contraceptive Research
  • RESEARCH LEADS
  • Female Methods
  • Male Methods
  • Modifications of Existing Methods
  • METHODS AVAILABLE OUTSIDE THE UNITED STATES
  • CONCLUSION
  • 4 Values and Contraceptive Development
  • ROOTS OF AMERICAN VALUES ON CONTRACEPTION
  • Historical Perspectives
  • Religious Perspectives
  • Legal Perspectives
  • CONTEMPORARY VALUE CONFLICTS: STERILIZATION AND ABORTION
  • The Link Between Contraceptive Development and Abortion
  • RU-486
  • WOMEN'S PERSPECTIVES ON REPRODUCTION AND SOCIAL ROLES
  • CONCLUSION
  • 5 Organizational Structure of Contraceptive Development
  • A DIVERSITY OF EXPERTISE
  • The Pharmaceutical Industry
  • Small Firms
  • Universities
  • Nonprofit Organizations
  • Government and Private Funding Organizations
  • The World Health Organization
  • COLLABORATIVE EFFORTS IN CONTRACEPTIVE DEVELOPMENT
  • Industry-University Collaboration
  • Competitive Aspects of Contraceptive Development
  • International Collaboration
  • STRENGTHENING THE PROCESS OF CONTRACEPTIVE DEVELOPMENT
  • Developing Country Institutions
  • National Scientific Centers in the United States
  • CONCLUSION
  • 6 Funding for Contraceptive Development.
  • FUNDING FOR CONTRACEPTIVE DEVELOPMENT
  • Pharmaceutical Industry Funding
  • Federal Funding
  • Foundation Funding
  • Funding Worldwide
  • World Health Organization
  • TRAINING
  • RECOMMENDATIONS
  • CONCLUSION
  • 7 Regulation and Contraceptive Development
  • THE DEVELOPMENT PROCESS
  • THE REGULATION PROCESS
  • FDA's Regulation of Drugs
  • Standards of Approval: Safety
  • Toxicological Testing of Contraceptive Drugs
  • The Case of Depo-Provera
  • The Appropriateness of Current Safety Requirements for Contraceptive Drugs
  • Standards of Approval: Effectiveness
  • The Risk-Benefit Trade-off
  • Patent Life and Profitability
  • FDA's Regulation of Medical Devices
  • Impediments to FDA Approval
  • Postmarketing Surveillance
  • CONTRACEPTIVE REGULATION: AN INTERNATIONAL PERSPECTIVE
  • Regulation in Europe
  • Regulation in Developing Countries
  • The World Health Organization's Role
  • RECOMMENDATIONS
  • CONCLUSION
  • 8 Products Liability and Contraceptive Development
  • THE LEGAL TERRAIN
  • SOURCES OF DATA
  • TRENDS IN LITIGATION INVOLVING CONTRACEPTIVES
  • Intrauterine Devices
  • Oral Contraceptives
  • Other Contraceptives
  • PRODUCTS LIABILITY RULES
  • Warranty
  • Fraudulent Misrepresentation
  • Negligence
  • Strict Liability in Tort
  • CASE STUDIES
  • The Dalkon Shield Intrauterine Device
  • Other Intrauterine Devices
  • Oral Contraceptives
  • Other Contraceptives
  • PRODUCTS LIABILITY INSURANCE AND CONTRACEPTIVE DEVELOPMENT
  • Causes of the Insurance Crisis
  • Cost and Availability of Liability Insurance for Contraceptives
  • Responses to the Crisis
  • Responses by Insurers
  • Responses by Policy Holders
  • Responses by State Legislatures
  • CONCLUSIONS AND RECOMMENDATIONS
  • Possible Elements of a Statute
  • The FDA Defense
  • Effect on Products Liability Cases
  • CONCLUSION
  • 9 Contraceptive Development: Obstacles and Opportunities.
  • THE NEED FOR NEW METHODS
  • RESEARCH LEADS
  • VALUES
  • ORGANIZATIONS AND RESOURCES
  • REGULATION
  • LIABILITY
  • A FINAL WORD
  • References
  • Legal Cases Related to Contraceptive Development
  • Glossary
  • Index.

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