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米国連邦食品医薬品局(FDA) 2017-2年版 全3巻

Food and Drug Administration, 4th Edition, 2017-2 Edition

James T. O'Reilly, Katharine A. Van Tassel

3 vols. Paper., 2017年11月刊(年2回刊行)

Thomson Reuters (CBC), USA. ISBN: 9780314977243

¥154,626

在庫あり

連邦食品医薬品局(FDA)に関わる全ての実務手続、執行態様、裁判手続などを網羅的に解説し、最高裁および多くの巡回区・地方裁判所による引用実績を誇る文献。輸出入規制、薬品・医療機器の認可手続、州の規則、捜査・警告活動など、FDAに関する法と手続を総合的に解説し、関連する書式などの資料を収録しています。

【Table of Contents】

1. Introduction

2. Structure of the Food and Drug Administration

3. The Food and Drug Administration: A Brief History

4. Food and Drug Administration Policy Making

5. Hearings

6. Administrative Enforcement

7. The FDA in Court: Civil Enforcement Actions

8. The FDA in Court: Criminal Enforcement Actions

9. Food Safety and Quality Issues

10. Food Regulation: Marketing, Nutrition and Dietary Supplements

11. Food Additives

12. History and Evolution of the Modern FDA Regulatory Categories and Definitions: When Is a Drug a “Drug” and Not a Food, Vitamin, Dietary Supplement, or Functional Food?

13. Drug Regulation: Approvals and Generics

14. Drug Conflicts: Rejections, Enforcement and Litigation Issue

15. Drug Reporting, Marketing and International Issues

16. Animal Drugs and Feeds

17. Cosmetics

18. Medical Devices

19. Radiological Products

20. Inspection

21. Product Recalls

22. Openness and Publicity

23. Good Practices Regulations

24. FDA and Other Federal Agencies

25. FDA and State Governments

26. Products Liability and the Food and Drug Administration

27. The Food and Drug Administration and Science Issues

28. Import and Export Issues

29. FDA and Tobacco Products

APPENDIX A. Food, Drug, and Cosmetic Act, as amended

Table of Laws and Rules

Table of Cases