【米国医療法律家協会編：生命科学に関する法的基礎知識 薬品、医療器具、バイオ技術 第２版】
The Fundamentals of Life Sciences Law: Drugs, Devices, and Biotech 2nd ed. paper xxxvi, 470 p., with CD-ROM 14
内容
目次
1. Introduction to the Regulation of Drugs / 2. Introduction to the Regulation of Medical Devices / 3. Introduction to the Regulation of Biologics / 4. Regulation of Industry-Sponsored Clinical Trials / 5. Key Federal Agencies: Roles and Responsibilities / 6. Regulation of Advertising, Promotion and Distribution of Drugs, Medical Devices and Biologics / 7. Life Sciences: Fraud and Abuse / 8. Antitrust Issues / 9. Privacy Issues / 10. State Regulation of Life Sciences Companies / 11. Intellectual Property / 12. Payment and Reimbursement Issues in Clinical Trials / 13. International Issues / 14. Life Sciences Transactions and Licensing / Glossary
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