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Developing new contraceptives : obstacles and opportunities / Luigi Mastroianni, Jr., Peter J. Donaldson, and Thomas T. Kane, editors.
- Format:
- Book
- Language:
- English
- Subjects (All):
- United States Food and Drug Administration.
- Contraceptives--Research--United States.
- Contraceptives.
- Contraceptive drugs--Research--United States.
- Contraceptive drugs.
- Contraception--trends.
- Contraceptive Agents.
- Contraceptive Devices.
- Research.
- Medical Subjects:
- United States Food and Drug Administration.
- Contraception--trends.
- Contraceptive Agents.
- Contraceptive Devices.
- Research.
- Physical Description:
- 1 online resource (205 pages) : illustrations
- Edition:
- 1st ed.
- Place of Publication:
- Washington, D.C. : National Academy Press, 1990.
- Language Note:
- English
- Summary:
- This report is the work of committees of the National Research Council and the Institute of Medicine. It analyzes the process by which contraceptives are developed and approved for use in the US and suggests ways to change that process to facilitate the development of safer, more effective, more con
- Contents:
- 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
- 3 The Current Status of Contraceptive Research
- RESEARCH LEADS
- Female Methods
- Male Methods
- Modifications of Existing Methods
- METHODS AVAILABLE OUTSIDE THE UNITED STATES
- 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
- 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
- 6 Funding for Contraceptive Development.
- FUNDING FOR CONTRACEPTIVE DEVELOPMENT
- Pharmaceutical Industry Funding
- Federal Funding
- Foundation Funding
- Funding Worldwide
- World Health Organization
- TRAINING
- RECOMMENDATIONS
- 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
- 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
- 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
- 9 Contraceptive Development: Obstacles and Opportunities.
- THE NEED FOR NEW METHODS
- VALUES
- ORGANIZATIONS AND RESOURCES
- REGULATION
- LIABILITY
- A FINAL WORD
- References
- Legal Cases Related to Contraceptive Development
- Glossary
- Index.
- Notes:
- Bibliographic Level Mode of Issuance: Monograph
- Includes bibliographical references and index.
- Other Format:
- Print version: Developing new contraceptives.
- ISBN:
- 9786610212828
- 9781280212826
- 1280212829
- 9780309564526
- 0309564522
- 9780585155203
- 0585155208
- OCLC:
- 607897730
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