本論文主要係討論美國新藥申請上市核准的有效性判斷及其相關問題研究，分為六章，第一章：緒論；第二章：美國核准新藥上市法制及其內涵；第三章：美國申請新藥上市核准的有效性判斷；第四章：美國新藥核准上市後有效性的行政監管法制；第五章：美國新藥獲准上市後有效性的司法監管法制：第六章：結論。
本論文的主要貢獻，係於第三章首先提出「藥品的有效性宣稱理論」，闡明一項藥品在客觀上可能的療效範圍與申請人所決定要申請上市核准的有效性之內容、水準及範圍不同。而申請人就其藥品所宣稱的有效性之內容、水準及範圍，在規範面要求應以「實質證據」證明其藥品的有效性，所謂「實質證據」係由具領域內專業知識及經驗之專家進行充分且受良好控制之臨床試驗所取得之數據，並得由FDA之專業知識及經驗之專家作成公正負責地作成該藥品在其標示或所擬議之標示的使用條件下，具有其宣稱所表示要具有的效果之結論所組成之證據。其有關之細節內容，本論文均從美國法制作了相當精細地探討，並詳實正確地援引規範依據，本文也從科學面向如何證明一項藥品的有效性，包括顯著性試驗、等效性試驗、優效性試驗及非劣效性試驗。並從FDA審查及法院判決實務，再得出藥品有效性的兩個重要核心內涵：統計上顯著性與臨床上顯著性，本論文於此也做出有意義的討論，並對藥事法的研究作出貢獻。
本論文的第四章，係從行政監管觀點，提出「藥品的有效性宣稱理論」、「藥品上市前核准或許可理論」與「藥品據實標示理論」，作為藥品獲准上市後有效性行政監管的界限，以及作為「標示上使用」及「標示外使用」（習慣上稱為「標籤外使用」）的推論與分析之基礎。「標示外使用」是就獲准上市之藥品作未經FDA核准的使用，在立法政策上，醫師的「標示外處方」被承認為醫學實踐的一部分，FDA不得加以干預或限制，但醫師除處方以外之「標示外使用」（如銷售、廣告、促銷）並非屬於醫學實踐的一部份，仍受「食品藥品及化妝品法」（FDCA）關於「標示不實」（misbranded）規定的規範。製造商的「標示外使用」則應受FDCA關於「標示不實」規定的規範，為法所禁止的行為（21 U.S.C.§§331,333），但藥品製造商的標示外使用，除直接銷售、促銷藥品外，亦有間接的方式如分發討論其藥品之標示外使用科學期刊或教科書重印本（即「持久性材料」），贊助繼續醫學教育（CME）或醫學研討會或論壇活動，並分發上開持久性材料或有意地在會議中提出或突顯其藥品的標示外使用之問題。就此，究係屬傳播真實且有益的科學資訊？抑係非法的標籤外促銷行為？應否受聯邦憲法第一修正案之言論自由（商業性言論）的保護，在美國引起許多的訴訟案及學界爭議。什麼是「標示外使用」的本質？贊成論與反對論」之理由又是什麼？雖然美國聯邦地方法院在W.L.F. v. Friedman案（1998）及聯邦上訴法院在United States v. Caronia案（2009），先後宣告FDA發布的各項指引文件及FDCA之標示不實規定均違憲無效，並認定製造商的「標示外之促銷」屬於真實的、非誤導的，且為合法的言論，但本論文則從各種觀點持反對論之見解，認為該藥品製造商對其藥品的「標示外之促銷」，係一項虛偽不實的、誤導的，且為不合法的言論。
再者，本論文於第五章，係從司法監管的觀點，探討美國「虛偽請求法」（The False Claim Act）責任及侵權行為法的嚴格責任法制，對於藥品製造商為「標示外促銷」行為，誘使醫師為標示外處方及藥師標示外調劑向美國Medicare或Medicaid請求償付，應否負虛偽請求之民事賠償責任？此外，本論文也介紹美國FDA或司法部就此的執法政策及其成效。最後，該標示外促銷，係對於藥品的標示上未為「充分的使用說明」「充分的不安全使用警告」之行為，應否負侵權行為責任？本論文也作了詳細的分析與討論。尤其，本論文認為在FDCA領域之藥品的標示外促銷之「虛偽性」，使Medicare或Medicaid或其他保險計畫除了少數例外之情形，均不將藥品的標示外使用列入償付項目，例如「覆蓋的門診藥品」（covered outpatient drugs）。藥品製造商就其藥品的標示外促銷，誘使醫師作標示外處方，並透過處方箋的某種合規之記載，而造成政府或Medicare或Medicaid系統的償付者，構成醫療保健欺詐，該藥品製造商就此應負FCA責任。由此觀之，FDCA領域之藥品的標示外促銷的「虛偽性」與FCA領域之提出對政府償付請求的「虛偽性」，兩者相關，但並非同一，且違反FDCA的行為，未必違反FCA，被告應否負擔FCA責任，應就該項對美國政府的償付請求本身是否具有「虛偽性」加以判斷。
本文最後結論，總結本文的精要，並與我國藥事法作相關法制作比較，並提出建議。本文囿於篇幅，討論範圍，僅限於「藥品」，不包括醫療器材。

Doctoral Dissertation Title
Study on the Effectiveness Judgment of Approving the Application for New Drugs and It’s Related Issues in U.S.
Author’s Name：Hsien-Teng Su
Advisor’s Name：Ing-Ling Hou, Dr. jur.
Department & College：Department of Law, National Cheng Kung University

SUMMARY
The theme of this dissertation is to discuss the effectiveness Judgment of approving a new drug application and it’s related issues in U.S.. First, from the industry perspective, to explore the sponsor how to design and conduct adequate and well-controlled investigations and the applicant how to determines the effectiveness claim of a drug and its conditions of use, level and scope. Second, from the normative side, to discuss how to prove the applicant's effectiveness claim of the drug and the indications and conditions of use contained in the labeling with substantial evidence and it’s quantity. Then, from the scientific viewpoint, to investigate how to prove the effectiveness of the drug with the designs of investigation, and why it is necessary to be statistically significant and clinically significant as an important connotation of drug effectiveness. Secondly, from the perspective of administrative regulation and judicial supervision after the listing of a new drug, the issues related to the approved on-labeling and the unapproved off-labeling are discussed, especially the relationships between the drug manufacturer ’s off-labeling use and the misbranded provision in FDCA, and the complex issues of the off-labeling promotion and commercial freedom of speech protected by the First Amendment. Finally, to discuss the question of whether the drug manufacturer's off-labeling use should bear the responsibility of False Claim Act and the product liability of the tort.
Key words: claim of effectiveness, substantial evidence, statistical significance ,clinical significance, off-labeling use, False Claim Act
INTRODUCTION
This dissertation mainly discusses the effectiveness judgment and related issues of approving a application of new drug (NDA) in the United States. It is divided into six chapters, the first chapter: the introduction; the second chapter: the U.S. approved new drug listing legal system and its connotation; the third chapter: the effectiveness judgment of approving a application of new drug (NDA) in U.S. ; Chapter 4: How to regulate the effectiveness of a new drug in the United States after the approval of the listing ; Chapter 5: The judicial regulatory system for the effectiveness of new drugs approved for listing in the United States: Chapter VI: Conclusions.
The main contribution of this dissertation is to firstly put forward the "the theory of the claim/purport of effectiveness for drug " in the third chapter, to clarify that the scope of the objectively possible therapeutic efficacy of a drug is different from the content, level and effectiveness of the applicant's decision to apply for listing approval. The applicant's requirements for the efficacy, content and scope of the drug's claims should be demonstrated in the form of "substantive evidence". The term “substantial evidence” means evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof. Its relevant details, this paper will make a fairly precise discussion from the U.S. law, and have invoked the normative basis in a detailed and correct manner. This article also explains how to prove the effectiveness of a drug, including the significance test, the equivalence test, the superiority test, and the non-inferiority test. And from the FDA review and court judgment practice, and then draw two important core connotations of drug effectiveness: statistical significance and clinical significance, this paper also makes a meaningful discussion, and contributes the study of the drug law.
The fourth chapter of this dissertation puts forward the "the theory of claim of effectiveness for drug", "drug premarket approval or clearance theory" and " the theory of drugs labeling should based on approved content " from the perspective of administrative regulation, as the boundaries of administrative regulation of the effectiveness for a drug after it is approved for listing, and as the basis of inference and analysis of "on- labeling use" and "off-labeling use" (commonly known to as "off-label use"). "Off-labeling use" is a approved drug for unapproved use . In the legislative policy, a physician's "off-labeling prescription" is recognized as part of medical practice, and the FDA should not intervene or limit it. But a physician's "off-labeling use" (such as sales, advertising, promotion) other than prescriptions is not part of the medical practice and is still regulated by the "misbranded" provisions of the Food, Drug, and Cosmetic Act (FDCA). The drug manufacturer's "off-labeling use" is subject to the FDCA's "misbranded" provision, which is prohibited by the FDCA（21 U.S.C.§§331,333）, but the drug manufacturer's off-labeling use, in addition to direct sales, promotion of drugs, there are also in indirect ways to distribute a scientific journal or textbook reprint (i.e. “enduring material”), to sponsor the continuing medical education (CME) or the activity of medical seminars or forums, and to disseminate the enduring materials or to present or highlight intentionally the issue of the off-labeling use of it's drug at meetings. For this circumstance,“is this a true and useful scientific information?”or“Is it illegal to off-labeling promotion? Whether it should be protected by the freedom of speech (commercial speech) of the First Amendment, has caused and raised many lawsuits and academic disputes in the United States. What is the essence of "off-labeling use"? What is the reason for the theory of "the pros and cons of off-labeling use" ? Although the United States District Court in the W.L.F. v. Friedman case (1998) and the Federal Court of Appeal in the United States v. Caronia case (2009), it had declared respectively that the guidelines issued by the FDA and the FDCA's misbranded provisions are unconstitutional, and found that the manufacturer's “off-labeling promotion” is a true, non-misleading, and legal speech, but this dissertation holds the opinion of opposition from various viewpoints, and think that the drug manufacturer’s “off-labeling promotion” of it’s drug is a false, misleading, and illegal speech.
Furthermore, in the fifth chapter, this dissertation explores the liability of the "The False Claim Act(FCA)" and the strict liability of Tort in common law from the perspective of judicial supervision, and the "off-labeling promotion" for pharmaceutical manufacturers to induce the physician and the pharmacist to present the false claim of the U.S. Medicare or Medicaid reimbursement for the off-labeling prescription /dispense . Should there be a civil liability for the false claim? In addition, this dissertation also introduces FDA or the Ministry of Justice's enforcement policy and its results in the U.S.. At last, the off-labeling promotion is not a "adequate use instructions" or "full unsafe use warning" for the labeling of drugs. Should it be held liable for infringement of tort ? This dissertation also makes a detailed analysis and discussion. In particular, this dissertation thinks that the “falsity” of off-label promotion of drugs in the field of FDCA does not allow Medicare or Medicaid or other insurance plans to include the “off-labeling use ” of drugs in reimbursement items (such as “covered outpatient drugs ”) with a few exceptions. The drug manufacturer's off-labeling promotion of its drug, inducing the physician to make an off-labeling prescription, and causing the government or Medicare or Medicaid system to pay through a certain compliance record of the prescription, constituting medical health care fraud, the drug manufacturer should be responsible for FCA. From this point of view, the "falsity" of the off-labeling promotion of drugs in the FDCA field and the "falsity" of the FCA field for the claim of government's reimbursement are related, but not the same, and the violation of FDCA does not necessarily violate the FCA. Whether the defendant should bear the responsibility of the FCA should rely on whether the reimbursement claim to the U.S. government itself has "falsity" to judge.
The final conclusion of this dissertation summarizes the essentials of this paper and compares it with the relevant laws of Pharmacy Law of R.O.C.(TAIWAN)and makes some recommendations. This dissertation is limited to the paper length, the scope of discussion is only limited to "drug" and does not include medical device.
MATERIALS AND METHODS
The literature collection of this dissertation mainly uses the "data collection method". First, to find out the laws and their subsidiary regulations related to the effectiveness of drugs in the U.S., including the FDCA of 1938/1962, the FDAMA, and the PHSA, and its subsidiary regulations, including“Investigational New Drug Application” (21 CFR Part 312), “Applications For FDA Approval To Market A New Drug” (21 CFR Part 314), “Labeling” (21 CFR Part 201), and “Prescription Drug Advertising” (21 CFR Part 202) and so on. Second, to collect relevant guidance documents issued by the FDA, such as “Guidance for Industry- Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products.(1998)”, “Non-Inferiority Clinical. Trials to Establish. Effectiveness. Guidance for Industry(2016)”, etc., and Relevant guidelines issued by ICH, such as "E9: Statistical Principles for Clinical Trials (1998)", " E10: Choice of Control Group and Related Issues in Clinical Trials(2000) "etc.. Again, for specific research subtopics (such as off-label use, false requests, etc.), browse the official websites such as FDA, NCBI, SSRN or N. Eng.J.Med., databases of scientific journals, and law reviews of law schools or universities in the U.S. and then the outdated regulations or FDA Notices through the Federal Register or the Library of Congress website. Finally, the jurisprudence of the Federal Courts is available on the Find Law or through Google search. Then, the various information and materials collected will be studied or read. The research subtopics of this dissertation will be analyzed through the "inductive method" to understand the research connotation and direction of each subtopics of the professional science, statistics and law. Furthermore, from the process of translate and read the federal court's decisions, learn how the American society operates the court, how the specific disputes attack and defend, the perspective of thinking, and the court's explanation of precedents and legal reasoning methods, all of which help to think about the breadth and depth of the problem. And then use the "deductive method" to analyze the various aspects of the problems involved in the subtopics areas and their possible solutions.
RESULTS AND DISCUSSION
The results of this dissertation is to to put forward three theories of "the theory of the claim/purport of effectiveness for drug ", "drug premarket approval or clearance theory" and " the theory of drugs labeling should based on approved content " as the basic structure of this dissertation . First, based on the ""the theory of the claim/purport of effectiveness for drug ", the scope of the "objective efficacy" of a drug and the "subjective efficacy " claimed by the applicant are distinguished. The applicant should propose the substantial evidence to demonstrate the scope of the "subjective efficacy " claimed, together with the corresponding conformity labeling (including label, inner/outer package and package insert), is submitted to the FDA for approval and listing, and after being reviewed and evaluated by the FDA to confirm its safety and effectiveness in use, it will be approved for listing. Based on the ""drug premarket approval or clearance theory",the applicants should market their drugs only with approved the scope of the "claims of effectiveness " and labeling of their drugs. Once the drug has been approved for marketing, the applicant (mainly the drug manufacturer) has an obligation to comply with the “the theory of drugs labeling should based on approved content ”, if it exceeds the range described or not described in the labeling, will constitute " off-labeling" . The "off-labeling use" of the drug is essentially a test that proves to be ineffective, and proves to be effective with inadequate trial or not tested at all, and has a high risk of safety and efficacy in use. In the regulatory policy, FDA will also prohibit the “off-labeling use”to implement the integrity and consistency of the drug regulatory system and to ensure the safety and effectiveness of the drug. FDCA stipulates that if a labeling relates to “false or misleading" or "the lack of adequate instructions for use or adequate safety warnings" should be considered as "misbranded". The "off-labeling use" not only violates the FDCA's misbranded provisions and constitutes a criminal offence, but also the "off- labeling " promotion, dissemination and distribution should be considered as a " false, misleading and illegal " commercial speech, unprotected by the First Amendment, and even the "off-labeling use" of drugs, have caused to submit a false claims to the government or health care plans , resulting in a unnecessary or improper reimbursement, and also causing problems with FCA liability. If therefore caused the patient's injury, the drug manufacturer will bear a product liability of tort in common law.
CONCLUSION
1. The safety and effectiveness of the drug is the FDCA's core. When the applicant
Submits s NDA to FDA, he should present the “substantial evidence” together with the corresponding conformity labeling to demonstrate the safety and effectiveness of the drug.
2. The "off- labeling " promotion, dissemination and distribution should be considered as a " false, misleading and illegal " commercial speech, unprotected by the First Amendment.
3. The "off-labeling use" of drugs, have caused to submit a false claims to the government or health care plans for reimbursement, and the drug manufacturer would or might be liable for a FCA liability, and even bear the product liability of tort in common law.

參考文獻
甲、中文部分：
一、書籍：
【Chapter 3】
1. 林惠玲、陳正倉，統計學方法與應用，雙葉書廊有限公司，上、下冊(2011年4月4版增訂)。
2. 陳敏，行政法總論，作者自行發行，神州圖書經銷，頁342、392(2003-3版)。

二、期刊：
【Chapter 1-2】
1. 蘇顯騰，論未經核准之試驗用藥品的擴大使用法制--以美國法制為論述核心，成大法學，第34期，第157-239頁(2017年12月)。
【Chapter 3】
1. 黃欽、趙明，對臨床試驗統計學假設檢驗中非劣效、等效和優效性設計的認識，中國臨床藥理學雜誌 第23卷第1期，頁65(2007年1月(總第105期))。
【Chapter 4】
1. 林子儀，言論自由的理論基礎，台大法學論叢，第18卷，第1期，第239-240 頁(1988)。

三、論文：
1. 廖建瑜，論臺灣處方藥仿單外使用之管制，國立成功大學法律系博士論文，第31-38頁(2013)。
2. 蔡立群，論現代產品責任法抗辯事由－以美國法之瑕疵類型為中心，中國文化大學法律學研究所碩士論文，頁78-82(2008)。
乙、英文部分：
A、Law:
【Chapter 1-2】
1.21st Century Cure Act, Pub.L.114–255.
2.21st Ccentury Cure Act, Sec.3001.,incorporated into FDCA Sec. 569C(c)(21 U.S.C.360bbb-8c(c)).
3.21st Ccentury Cure Act, Sec.3023.,incorporated into FDCA Sec.505E(b)(21 U.S.C.355f (b)).
4.70(2) Food Drug Law J.315,315-317(2015).
5.CDER,CDER Approval Times for Priority and Standard NDAs and BLAs Calendar Years 1993–2016,Pub. L. No. 59-384, 34 Stat. 768 (1906).
6.702-03(codified as amended at 42 U.S.C. §§ 262(a), 264 (2012)).
7.Drug Amendments of 1962, Public Law 87-781, 76 Stat.780.(1962).
8.Drug Amendments of 1962 Secs. 107 (c)(4).
9.Drug Amendments of 1962, Public Law 87-781, 76 Stat.780.
10.Drug Amendments of 1962 Secs. 107 (c)(2)(4),(c)(3)(B),Public Law 87-781,76 Stat. 780.
11.FDCA of 1938, 201(p),(p)(1)(2).(21 U.S.C. 321(p),(p)(1)(2)).
12.FDCA of 1938, 505(b).(21 U.S.C. 355(b)).
13.FDCA of 1962, 505(b),(d)(5),(e)(3).(21 U.S.C. 355(b),(d)(5),(e)(3))
14.Federal Anti-Tampering Act,U.S.C. TITLE 18.
15.FDCA §201(aa)(p)(1962)(21 U.S. Code §321(aa)(p))
16.FDCA of 1938, 201(p)(1)(2)(21 U.S.C. 321(p)(1)(2)).
17.FDCA of 1938, 201(p),(p)(1) (21 U.S.C. 321(p),(p)(1)).
18.FDCA of 1962, 505(b) (21 U.S.C. 355(b))
19.The Prescription Drug User Fee Act (PDUA)（H.R.6181,）.
20.Public Health Service Act (1944) , ch. 373, §§ 351, 351(a), 361, 58 Stat. 682, 702-03(codified as amended at 42 U.S.C. §§ 262(a), 264 (2012)).
21.Pub. L. No. 59-384, 34 Stat. 768 (1906).
22.Pub. L. No. 75-717, 52 STAT 1040(1938).
23.Pub.L.No.105-115., the Food and Drug Administration Modernization Act（FDAMA）of 1997.
24.S.Res.287, The Drug Price Competition and Patent Term Restoration Act of 1984.
25.15 U.S.C. Chapter 39 - FAIR PACKAGING AND LABELING PROGRAM.
26.21 U.S.C. Section 371(a).
27.21 U.S.C.§355(b),(b)(1),(d),(d)(2)(5),(i)(1)(4),(j)(1)(2).
28.21 U.S.C. Section 360J(f).
29.21 U.S. C.§393(1)(2).
【Chapter 3】
1. Federal Food and Drugs Act of 1906, Pub. L. No. 59-384, 34 Stat. 768 (1906).
2. Federal Food, Drug , and Cosmetic Act of 1938, FDCA Public Law 75-717, 52 STAT 1040(1938)(Sec. 201(p)(1)(2), 505(b) (21 U.S.C. 201(p)(1)(2), 355(b)).
3. Drug Amendments of 1962, Pub.L.No.87-781, 76 Stat.780.(1962)(Sec. 107(a)(b)).
4. Federal Food, Drug , and Cosmetic Act of 1962,(Sec 107(c)(2) (3)(B). (c) (4), 201(g)(1) (p) ,505(b), (d)(5) ,(e)(3)(5), (d)(7), (j)(4)(C)(ii) )(21 U.S.C. 321(g)(1) (p).355(b)(5), (d)(5), (e)(3)(5),(d)(7), (j)(4)(C)(ii)) Pub.L.No.87-781, 76 Stat.780.(1962)
5. Public Health Service Act, (58 Stat. 682, As Amended Through P.L. 115-123, Enacted February 9, 2018) (Sec. 351(a)(i)(1)(262(a)(i)(1))
6. Food and Drug Administration Amendments Act of 2007, (Sec. 801)
7. FDA Modernization Act of 1997, Pub. L. No. 105-115, § 113, 111 Stat. 2296 (42 U.S.C. 282(j)(3)(A))(2012)).
8. 21st Ccentury Cure Act, (Sec.3001.,incorporated into FDCA Sec. 569C(c)(21 U.S.C.360bbb-8c(c)).
【Chapter4】
1.Administrative Procedure Act §§2(a),(e), 9, §706(2)(B) (Pub. L. No.404-79).
2.FDCA §201(I)(k)(m)(n)( 21 U.S.C. 321(I)(k)(m)(n)).
3.FDCA §301(a)(b)(c)(d)(k)(21 U.S.C. 331(a)(b)(c)(d)(K)).
4.FDCA §303(a)(21 U.S.C. 333(a)).
5.FDCA §423（21 U.S.C. §350l）
6.FDCA §501(21 U.S.C. 351).
7.FDCA §502,(a)(1),(f),(f)(1)(21 U.S.C. 352,(a)(1),(f),(f)(1)).
8.FDCA §503(b)(2).
9.FDCA §505(a), (e)(1) (2) (3) (4) (5), (k)(1) ( 21 U.S.C. §355(a), (e)(1) (2) (3) (4) (5), (k)(1)).
10.FDCA§505(a),(C)(5)(A)(B)(D),(d)-(e),(e)(k)(1),(e)(1)(2)(3)(4) (5),(k)(1)(o)(3), ( 21 U.S.C.§355(a), (C)(5)(A)(B)(D),(d)-(e),(e) (k)(1),(e)(1) (2) (3) (4) (5),(k)(1),(o)(3)).
11.FDCA §505-1(a)(1)(21 U.S.C.§355-1(a)(1)).
12.FDCA §518(e)(21 U.S.C. §360h(e))
13.FDCA §535(a)(21U.S.C. 360ll).; 21 C.F.R.1000–1050.
14.FDCA §551(21 U.S.C. §360aaa(a)).
15.FDCA §569D (21 U.S.C. §360bbb-8d).
16.FDCA §908(c) (21 U.S.C. §387h(c)).
17.FDCA §1006 (21 U.S.C. 396).
18.FDAMA,§503A, 21 U. S. C. §353a ,111 Stat. 2328(1997).
19.FDAMA Section 401(a) ((a) IN GENERAL.—Chapter V (21 U.S.C. 351 et seq.)
20.Public Health Service Act (PHS Act) §351(d) (42 U.S.C. 262(d))( Recall of product presenting imminent hazard; violations)
21.Public Health Service Act(PHS Act) §361(42 U.S.C. 264); 21 CFR Part 1271.440(Orders of retention, recall, destruction, and cessation of manufacturing).
22.The Fair Packaging and Labelmg Act §10(c).
23.Vt. Stat. Ann., Tit. 18 § 4631(e)(4).
24.21st Century Cures Act(Dec.13, 2016) , Sec. 3037(HEALTH CARE ECONOMIC INFORMATION.), Section 502(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(a)). , P. L.114–255, 130 STAT. 1033.
25.The Federal Food and Drugs Act (1906), Pub. L. No. 59-384, 34 Stat. 768.
26.21 U.S.C.§§331(a)(z), 331et seq.,333(a), 352(n)(3),353(b)(1)(B),(b)(2).,355(a),(d) paragraph 2,
27.21 U.S.C.§350a(f).
28.21 U.S. C.§350l.
29.21U.S.C§§360aaa et seq.
30.21 U.S.C.§360aaa(a),(b)(1)-(6),(c).
31.21 U.S.C.§360aaa-1.
32.21 U.S.C.§360aaa-4(b)(1).
33.21 U.S.C. § 360aaa-3(d).（按此項條文現已隨著FDAMA五年授權到期失效，而予以刪除）
34.21 U.S.C.§396(b).
【Chapter 5-6】
1.The Civil False Claims Act of Mar. 2, 1863, ch. 67, 12 Stat. 696 (current version at 31 U.S.C. §3729 (2018)).
2.The Federal Civil Penalties Inflation Adjustment Act of 1990.(28 U.S.C. 2461 note; Public Law 104–410).
3.21 U.S.C. §§331(a) & (d), 332(a), 333(a), 334(a)
4.28 U.S.C. 2461 note; Pub.L. No. 104-410.
5.31 U.S.C. §3729(a),(a)(1) (A)-(G)-(3), 9(b),(b)(1)(2) (2018).
6.31 U.S.C. §3730(a)(b)(1)-(5)(c)(1)-(5),(d)(1)-(4)(A) , (f), (h)(1)-(3) (2018).
7.31 U.S.C. §3731(b)(1)-(2)(2018).
8.42 U.S.C. §§1396b(i) (10), 1396r-8,(k) (3), (6),(c)(1)(C), (g) (1) (B) (i).
B、Regulation:
【Chapter 1-2】
1.21C.F.R. Part 312 Investigational New Drug Application(IND). (2016)
2.21 C.F.R. Part 314 Applications For FDA Approval To Market A New Drug (NDA). (2016)
3.21 C.F.R. §312.3(b) . (2018)
4.21 C.F.R. §312.50. (2018)
5.21 C.F.R. §312.52(b). (2018)
6.21 C.F.R. §312.20 ,(a)(c). (2018)
7.21 C.F.R. §312.23. (2018)
8.21 C.F.R. §312.40,(b)(2018). (2018)
9.21 C.F.R. §312.21,(a)-(c). (2018)
10.21 C.F.R. §312.32(c)(i). (2018)
11.21 C.F.R. §312.42(a)(b)(1)(2). (2018)
12.21 C.F.R. §314.2. (2018)
13.21 C.F.R. §314. (2018)
14.21 C.F.R. §130.40 (currently 21 C.F.R.§310.6),. (2018)
15.21C.F.R. §330. (2018)
16.21 C.F.R. §333. (2018)
17.21 C.F.R. §310.502. (2018)
【Chapter 3】
1.Rules and Regulations:C.F.R. 130.4(c)(1)(i), 28 Fed. Reg. 6377, 6378 (June 20, 1963).
2.Rules and Regulations: New Drugs, 39 Fed. Reg. 9750, 9755 (Mar. 13, 1974)
3.21 C.F.R. 130.40 (currently 21 C.F.R. 310.6)（Oct 31, 1972）
4.21 C.F.R. 202.1(e)(1).(3)(i) (2018)
5.21 C.F.R. 312.23(a)(6) (2018)
6.21 C.F.R. 314.125(b)(5) 126(a) (b)(2)(c) (i) (4)(5) (e) (v) (2018). .
7.21 C.F.R. 314.50(d)(5)(ii) (2018)
8.21 C.F.R. 314.92(1) (2018)
9.21 C.F.R. 202.1 (e)(4) (ii)(b) (2018)
10.21 C.F.R. 202.1 (e) (2)(7)(ii) (4)(ii)(b) (6)(vii)(2018)
11.21 C.F.R. 330.10 (a)(4) (ii) (2001)
12.21 C.F.R. 600.3 (s)
13.21 C.F.R. 601.25 (6)(2) (ii) (d)(2) (2012).
14.21 C.F.R. 1271.3 (d)
15.21 C.F.R. 1271.10(a) (2015).
【Chapter4】
1.21 C.F.R. Subpart A--General Provisions, Sec. 1.3(a).
2.21 C.F.R.§101.14.(c).
3.21 C.F.R. Part 107, Subpart E.
4.21 C.F.R.§201.5
5.21 C.F.R.§201.6(a)(b).
6.21 C.F.R.§201.56(a)(1)(2)(3),(d).
7.21C.F.R.§201.57(a)(b)(c),(c)(6)(i), 314.70 and 601.12.
8.21 C.F.R.§201.80.
9.21 C.F.R.§201.100, (c)(1).
10.21 C.F.R.§201.115
11.21 C.F.R.§201.128.
12.21 C.F.R.§202.1 (e)(3)(i),(e)(4)(i)(a) ,(e)(6)(i), (xi) (same).
13.21 C.F.R.§216.23.
14.21C.F.R.§300.50.
15.21 C.F.R.§310.515.
16.21 C.F.R.§314.80.
17.21 C.F.R.§314.81(b)(2),(b)(2)(i).
18.21 C.F.R.§810.
【Chapter 5】
1.21 C.F.R. §312.7.
2.Fed. R. Civ. P. §§9(b), 12(b)(6)
C、ICH：
【Chapter 1-2】
1.ICH, E9 Statistical Principles for Clinical Trials,1.2 Scope and Direction.
2.ICH, E10 Choice of Control Group and Related Issues in Clinical Trials.

【Chapter 3】
1.ICH, E4 Dose-Response Information to Support Drug Registration
2.ICH, E5(R1)Ethnic Factors in the Acceptab -ility of Foreign Clinical Data.
3.ICH, E6(R2): Guideline For Good Clinical Practice, 6. Clinical Trial Protocol and Protocol Amendment(s).
4.ICH, E9 Statistical Principles for Clinical Trials.
5.ICH, E10Choice of Control Group and Related Issues in Clinical Trials;
6.ICH, E17General principles for planning and design of Multi-Regional Clinical Trials.
D、Decision:
【Chapter 1-2】
1.Weinberger v. Hynson、Westcott＆Dunning,Inc, 412 U.S. 609,610(1973).
【Chapter 3】
1.Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 104 S. Ct. 2778, 81 L. Ed. 2d 694(1984).
2.FMC Corp. v. Unmack, 699 N.E.2d 893, 896(N.Y. 1998).
3.300 Gramatan Avenue Associates v State Division of Human Rights, 45 NY2d at 180 181).
4.Laws v. Celebrezze , 368 F.2d 640., cited by Mastro v. Apfel, 270 F.3d 171, 176 (1966) (4th. Cir. 2001).
5.Painting Co. v. NLRB, 298 F.3d 492, 499(6th Cir. 2002).
6.Serono Laboratories, Inc. v. Donna E. Shalala, et al., and Ferring Pharmaceuticals Inc., 158 F.3d 1313(D.C. Cir. 1998).
7.United States v. 225 Cartons, 871 F.2d 409, parapraph 28-39,45(1989).
8.United States v. Rutherford, 442 U.S. 544, 553, 99 S. Ct. 2470, 61 L. Ed. 2d 68(1979).
9.United States v. Shonubi, 895 F. Supp. 460, 471(footnote4)(E.D.N.Y. 1995) .
10.Warner-lambert v. Heckler, 787 F.2d 147, paragraph 32(3d Cir. 1986).
11.Weinberger v. Hynson、Westcott＆Dunning,Inc, 412 U.S. 609,610 (1973).
【Chapter4】
1.Aetna Life Ins. Co. v. Haworth , 300 U.S. 227, 240-41, 57 S.Ct. 461, 81 L.Ed. 617(1937).
2.Action on Smoking and Health v. Harris, 655 F.2d 236, 239 (D.C.Cir.1980).
3.Amax Land Co. v. Quarterman, 181 F.3d 1356, 1365 & n. 6(D.C.Cir.1999).
4.Aspirin Foundation of America, Inc, 740 F.2d 21 , at 34 (D.C. Cir. 1984).
5.Ashcroft v. ACLU, 542 U.S. 656, 665, 669 (2004).
6.Association of National Advertisers, 44 F.3d at 728,731.
7.AT & T v. FCC, 978 F.2d 727, 731-32(D.C. Cir.1993).
8.Board of Trustees of the State University of New York v. Fox, 492 U.S. 469, 477,478,481, 109 S. Ct. 3028,3035. 106 L. Ed. 2d 388(1989).
9.Board of Trustees of Leland Stanford Junior University v. Sullivan, 773 F. Supp. 472, 474(D.D.C. 1991).
10.Bolger v.Youngs Drug Products Corp., 463 U. S. 60, 71, n. 20 (1983).
11.Brown v. Entm't Merchs. Ass'n , 131 S.Ct. 2729, 2738 (2011) .
12.Carey v. Brown, 447 U.S. 455, 465(1980) .
13.Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm'n of N.Y. , 447 U.S. 557, 563–64 (1980).
14.Ciba-Geigy Corp.v. U.S. Environmental Protection Agency, 801 F.2d 430, 434,435(D.C.Cir.1986).
15.City of Houston v. Hill, 482 U.S. 451, 459(1987).
16.Central Hudson Gas and Electric Corp. v. New Service Comm'n of New York (447 US 557,563,569,100 S. Ct. 2343, 65 L. Ed. 2d 341.)(D.C.Cir.1988)
17.City of Cincinnati v. Discovery Network, Inc., 507 U.S. 410, 423, 426, 113 S. Ct. 1505, 123 L. Ed. 2d 99 (1993).
18.DeFreese v. United States, 270 F.2d 730 (5th Cir. )(1959), cert. denied, 362 U.S. 944, 80 S.Ct. 810, 4 L.Ed.2d 772 (1960).
19.Doe v. Bolton, 410 U.S. 179, 197, 93 S. Ct. 739, 35 L. Ed. 2d 201 (1973).
20.Dun & Bradstreet, Inc. v. Greenmoss Builders, Inc. , 472 U.S. 749, 759 n. 5, 105 S. Ct. 2939, 86 L. Ed. 2d 593(1985).
21.Edenfield v. Fane, 507 U.S. 761, 770,771,775, 113 S. Ct. 1792, 123 L. Ed. 2d 543(1993).
22.First National Bank of Boston v. Bellotti, 435 U.S. 765, 777,784, 785,98 S. Ct. 1407, 55 L. Ed. 2d 707(1978).
23.Friedman v. Rogers, 440 U.S. 13, 99 S. Ct. 887, 59 L. Ed. 2d 100(1979).
24.Florida Bar v.Went for It,Inc.,515 U.S. 618,635,115 S.Ct. 2371,132 L. Ed. 2d 541(1995).
25.FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 133(2000).
26.Friends of the Earth, Inc. v. Laid law Environmental Servs. (TOC), Inc., 528U.S. 167, ----, 120 S.Ct. 693, 708, 145 L.Ed.2d 610 (2000).
27.Greater New Orleans Broad. Assoc. v. United States, 527 U.S. 173, 194 (1999).
28.Holder v. Humanitarian Law Project, 130 S.Ct. 2705, 2724(2010).
29.In re R.M.J., 455 U.S. 191, 200,202,203,102 S. Ct. 929, 937,71 L. Ed. 2d 64(1982).
30.Ibanez v. Florida Department of Business and Professional Regulation , 512 U.S. 136, 146, 114 S. Ct. 2084, 129 L. Ed. 2d 118(1994) .
31.In re Kessler , 100 F.3d 1015(D.C.Cir.1996).
32.In Nutritional Health Alliance v. Shalala, 953 F. Supp. 526,529 (S.D.N.Y. 1997).
33.Kordel v. United States, 335 U.S. 345, 351, 69 S.Ct. 106, 110, 93 L.Ed. 52 (1948).
34.Keyishian v. Board of Regents, 385 U.S. 589, 603, 87 S. Ct. 675, 17 L. Ed. 2d 629(1967).
35.Laboratories v. Gardner, 387 U.S. 136, 148, 87 S. Ct. 1507, 1515, 18 L. Ed. 2d 681,30(1967).
36.Linmark Assoc., Inc. v. Willingboro , 431 U.S. 85, 97, 97 S. Ct. 1614, 52 L. Ed. 2d 155(1977) .
37.McKinney v. Alabama , 424 U.S. 669, 683 (1976).
38.National Council for Improved Health v. Shalala, 893 F. Supp. 1512, 1516-17(D.Utah 1995).
39.New York Times v. Sullivan, 376 U.S. 254, 266, 84 S. Ct. 710, 11 L. Ed. 2d 686(1964).
40.Ohralik v. Ohio State Bar Ass'n(436 U.S. 447, 455-56,98 S.Ct. 1912.) (1978).
41.Public Citizen Health Research Group v. Commissioner, Food & Drug Administration.
42.Pittsburgh Press Co. v.Pittsburgh Comm'n on Human Relations,413 US 376,93 S.Ct.2553,37 L. Ed.2d 669(1973).
43.Pacific Gas and Electric Co. v. Public Utilities Comm'n of California , 475 U.S. 1, 106 S. Ct. 903, 89 L. Ed. 2d 1 (1986)(utilities)
44.Pearson v. Shalala , 1998 WL 440621, Civ. A. No. 95-1865(GK)(D.D.C. Jan. 12, 1998).
45.Peel v. Attorney Registration and Disciplinary Comm'n of Illinois, 496 U.S. 91, 111, 110 S. Ct. 2281, 110 L. Ed. 2d 83.(1990)(Marshall, J., concurring)
46.Posadas de Puerto Rico Assoc. v. Tourism Co. of Puerto Rico(478 U.S. 328,341, 106 S. Ct. 2968, 92 L. Ed. 2d 266)(1986)
47.Price Waterhouse v. Hopkins, 490 U. S. 228, 251-252(1989).
48.R.A.V. v. City of St. Paul(1992), 505 U.S. 382,377, 386 .
49.Retkwa v. Orentreich, 584 N.Y .S.2d 710 (N.Y.Sup.Ct.1992).
50.Rubin v. Coors Brewing Co., 514 U.S. 476,490-491, 115 S. Ct. 1585, 131 L. Ed. 2d 532(1995) .
51.Sterling Drug, Inc. v. Cornish, 370 F.2d 82 (8th Cir. 1967).
52.States v. Concentrated Phosphate Export Ass'n, 393 U.S. 199, 203, 89 S.Ct. 361, 21 L.Ed.2d 344(1968) .  
53.Securities & Exchange Commission v. Wall Street Publishing Institute, Inc 851 F.2d 365, 372 (D.C.Cir.1988).
54.Shapero v. Kentucky Bar Ass'n , 486 U.S. 466, 476, 108 S. Ct. 1916, 100 L. Ed. 2d 475(1988) .
55.Sita v. Danek Med. Inc., 43 F.Supp.2d 245 (E.D.N.Y.1999).
56.Skilling v. United States, 130 S.Ct. 2896, 2929-30 (2010).
57.Sorrell v. IMS Health,Inc.,131 S.Ct. 2653-2668(2011).
58.Turner Broad., 512 U.S. at 642; Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm'n of N.Y., 447 U.S. 557, 563–64 (1980).
59.Turner Broadcasting System, Inc. v. F.C.C., 512 U.S. 622, 641–642,114 S. Ct. 2445, 129 L. Ed. 2d 497(1994).
60.Thompson v. Western States Medical Center, 535 U.S. 357,369,373,374(2002).
61.United States v. Sullivan, 332 U.S. 689, 68 S.Ct. 231, 92 L.Ed. 297 (1948).
62.United States v. W. T. Grant Co., 345 U.S. 629, 632, 73 S.Ct. 894, 97 L.Ed. 1303(1953).
63.United States v. Wiesenfeld Warehouse Co., 376 U.S. 86, 92, 84 S.Ct. 559, 563, 11 L.Ed.2d 536 (1964) .
64.United States v. An Article of Drug . . . Amodril Spancap.United States v. Articles of Drug, supra, 625 F.2d at 674(1975).
65.United States of America v. An Article of Drug…Diso-Tate(E.D.La., Sept. 28, 1976).
66.United States v. Evers,453 F. Supp. 1141 (1978).
67.United States v. Evers(, 643 F.2d 1043 (5th Cir)1981).
68.United States v. Rutherford, 442 U.S. 544, 557-58, 99 S. Ct. 2470, 61 L. Ed. 2d 68(1979).
69.United States v. General Nutrition, Inc., 638 F. Supp. 556, 562(W.D.N.Y.1986) .
70.U.S. Healthcare v. Blue Cross of Greater Philadelphia, 898 F.2d 914(3d Cir.1990).
71.U.S. v. Edge Broadcasting Co., 509 U.S. 418, 430, 113 S. Ct. 2696, 125 L. Ed. 2d 345(1993).
72.United States v. Caronia, 576 F.Supp.2d 385, 392 n.5 (E.D.N.Y.2008) .
73.United States v. Abbott Labs., No. 12–cr–26 (SGW) (W.D.Va. May 7, 2012).
74.United States v. Merck Sharp & Dohme Corp., No. 11–cr–10384 (PBS), ECF Doc. No. 30(D.Mass. May 18, 2012).
75.Virginia Bd. of Pharmacy v. Virginia Citizens Consumer Council, Inc.,, 425 U.S. 748,756-57,759, 762,770-72, 96 S. Ct. 1817, 48 L. Ed. 2d 346,Pp. 373-376(1976)(1994).
76.Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 629 ,612-14(1973).
77.Whalen v. Roe, 429 U.S. 589, 97 S. Ct. 869, 51 L. Ed. 2d 64 (1977).
78.Ward v. Rock Against Racism, 491 U.S. 781, 791,799, 109 S. Ct. 2746, 105 L. Ed. 2d 661(1989).
79.Webster's Ninth New Collegiate Dictionary (1990).
80.Wisconsin v. Mitchell , 508 U.S. 476, 489, 113 S. Ct. 2194, 2201-02, 124 L. Ed. 2d 436(1993).
81.Washington Legal Found. v. Kessler, 880 F. Supp. 26 ("WLF I") (D.D.C. 1995).
82.Washington Legal Foundation v. Friedman(D.D.C.1998),13 F. Supp. 2d 51,57-58,62-65 . ("WLF II")
83.Washington Legal Foundation v. Friedman, 36 F.Supp.2d 16, 18 (WLF II)(D.D.C.1999).
84.Washington Legal Found. v. Henney, 56 F. Supp. 2d 81,83,87("WLF III")(D.D.C.1999).
85.Washington Legal Found. v. Henney , 202 F.3d 331,335("WLF IV"); 65 Fed. Reg. 14,286-287.45Id(D.C.Cir.2000).
86.Whitaker v. Thompson, 239 F. Supp. 2d at 43,54(D.D.C. 2003).
87.Whitaker v. Tommy G. Thompson, 353 F.3d 947(DC Cir.2004).
88.Zauderer v. Office of Disciplinary Counsel, 471 U.S. 636, 646(1985).
89.44 Liquormart, Inc. v. Rhode Island,,517 U.S. 484,497, 501,505, n. 7, 116 S. Ct. 1495, 134 L. Ed. 2d 711 (1996).
【Chapter 5】
1.Anderson v.Owens-Corning Fiberglas Corp., 53 Cal.3d 987, 810 P.2d 549, 281 Cal.Rptr. 528(1991).
2.Beshada v. Johns- Manville Product Corp. , 447 A 2d 539(N.Y. 1982).
3.Boston & Me. Corp. v. Hampton, 987 F.2d 855, 866 (1st Cir. 1993).
4.Corley v. Rosewood Care Ctr., Inc., 142 F.3d 1041, 1050(7th Cir.1998) .
5.Coyne v. City of Somerville , 972 F.2d 440, 442-43(1st Cir.1992).
6.Correa-Martinez v. Arrillaga-Belendez, 903 F.2d 49, 51(1st Cir.1990).
7.D. Dobbs, et al., Prosser and Keeton on Torts § 44, at 303-04(5th ed. 1984).
8.Greenman v. Yuba Power Products, 59 Cal.2d 57, 27 Cal.Rptr. 697.the American Law Institute , Restatement of Torts,Second (1963).
9.Green v. American Tobacco Co., 391 F.2d 97(1968).
10.Gublo v. Novacare, Inc., 62 F. Supp. 2d 347, 355(D.Mass. 1999).
11.Hill v. Wilmington Chem. Corp., 279 Minn. 336, 340-44, 156 N.W.2d 898, 902-04(1968).
12.Hagood v. Sonoma County Water Agency, 929 F.2d 1416, 1421(9th Cir. 1991).
13.Harrison v. Westinghouse Savannah River Co., 176 F.3d 776, 783-84,788(4th Cir.1999) .
14.Hahn V Richter, 427 Pa Super 130, 628 A2d 860 (1993), app granted, 537 Pa 650, 644 A2d 736, 867-68 .(1994).
15.Iacampo v. Hasbro, Inc., 929 F. Supp. 562, 567(D.R.I.1996).
16.Medtronic, Inc. v. Lohr , 518 U.S. 470,485(1996).
17.Mulder v Parke Davis & Co., 288 Minn 332, 181 NW2d 882, 885(1970).
18.Magee v Wyeth Laboratories, Inc., 214 Cal App 2d 340, 29 Cal Rptr 322, 328(1963).
19.New England Data Servs., Inc. v. Becher, 829 F.2d 286, 292(1st Cir.1987).
20.Peterson v. Weinberger, 508 F.2d 45, 52 (5th Cir.)
21.Peterson v. Mathews, 423 U.S. 830, 96 S. Ct. 50, 46 L. Ed. 2d 47 (1975).
22.Pickens v. Kanawha River Towing, 916 F. Supp. 702, 705-06(S.D.Ohio 1996).
23.Robak v Abbott Laboratories., 797 F Supp 475(D Md 1992).
24.Riegel v. Medtronic, Inc.,552 U.S. 312(2008).
25.Retail Clerks v. Schermerhorn, 375 U. S. 96, 103(1963).
26.Sterling Drug, Inc., a Corporation, Appellant, v. Maxine F. Cornish, Appellee, 370 F.2d 82(8th Cir. 1967).
27.Thomas v. Winchester, 6 N.Y. 397(1852).
28.United States ex rel. Hopper v. Anton, 91 F.2d 1261, 1266-67(9th Cir. 1996).
29.United States ex rel. Franklin v. Parke-Davis, 147 F. Supp. 2d at 46,51.
30.United States ex rel. Lamers v. City of Green Bay, 168 F.3d 1013, 1020(7th Cir. 1999).
31.United States v. Bank of Farmington, 166 F.3d 853, 858 (7th Cir. 1999) (citing S. REP. NO. 99-345, at 2 (1986), reprinted in 1986 U.S.C.C.A.N. 5266, 5267).
32.United States v. Entin, 750 F. Supp. 512, 518(S.D. Fla. 1990).
33.United States v. McNinch, 356 U.S. 595, 598 (1958).
34.United States ex rel. Marcus v. Hess, 317 U.S. 537, 540,543-45, 63 S. Ct. 379, 87 L. Ed. 443(1943).
35.United States v. Cohn , 270 U.S. 339, 345–46(1926).
36.United States v. Rivera, 55 F.3d 703, 709 (1st Cir. 1995).
37.United States v. Richard Dattner Architects , 972 F. Supp. 738, 746–47(S.D.N.Y. 1997).
38.United States ex rel. Mazzola v. C.W. Roen Constr. Co., 183 F.3d 1088, 1092 (9th Cir. 1999).
39.United States v. Anderson , 579 F.2d 455, 460(8th Cir. 1978) .
40.US Ex Rel. Aranda v. Com. Psychiatric Centers, 945 F. Supp. 1485,1488-1889 (W.D. Okla. 1996).
41.United States ex rel. Walsh v. Eastman Kodak Co., 98 F. Supp. 2d 141, 147-148(D.Mass.2000).
42.United States ex rel. Thompson v. Columbia/HCA Healthcare Corp., 125 F.3d 899, 903(5th Cir. 1997).
43.United States ex rel. Thompson v. Columbia/HCA Healthcare Corp. , 20 F. Supp. 2d 1017, 1048-49 n.33(S.D.Tex.1998).
44.United States ex rel. Johnson v. Shell Oil Co., 183 F.R.D. 204, 206-07(E.D.Tex. 1998) .
45.United States ex rel. Wilkins v. North Am. Constr. Corp., 101 F. Supp. 2d 500, 513(S.D.Tex.2000).
46.United States v. Kensington Hosp., 760 F. Supp. 1120, 1125(E.D.Pa.1991).
47.United State ex rel. Pogue v. American Healthcorp, Inc., 914 F. Supp. 1507, 1513(M.D.Tenn.1996).
48.United States ex rel. Downy v. Corning, Inc., 118 F. Supp. 2d 1160, 1172-73(D.N.M.2000).
49.United States v. Neifert-White Co., 390 U.S. 228, 232-33, 88 S. Ct. 959, 19 L. Ed. 2d 1061(1968).
50.United States ex rel. Cantekin v. Univ. of Pittsburgh , 192 F.3d 402, 416(3rd Cir.1999).
51.United States v. White , 765 F.2d 1469, 1479-80(11th Cir.1985).
52.United States ex rel. Fallon v. Accudyne Corp ., 880 F. Supp. 636, 638 (W.D.Wis.1995).
53.United States v. Incorporated Village of Island Park, 888 F. Supp. 419, 434-36(E.D.N.Y.1995).
54.United States v. McClatchey, 217 F.3d 823, 835 (10th Cir.) 531 U.S. 1015, 121 S. Ct. 574, 148 L. Ed. 2d 492 (2000).
55.United States ex rel. Kneepkins v. Gambro Healthcare, Inc. , 115 F. Supp. 2d 35, 43(D.Mass.2000)(O'Toole, J.)
56.Wyeth v. Levine , 555 U.S. 555(2009).
57.Wilkins ex rel. United States v. Ohio, 885 F. Supp. 1055, 1061 (S.D.Ohio 1995).
58.Weinberger v Bristol-Myers Co. , 652 F Supp 187(D Md 1986).

E、FDA Report and Guidance:
【Chapter 1-2】
1.FDA,Guidance for Industry-Providing Clinical Evidence of Effectiveness for Human Drugs and Biological Products, Pp 1-2(May1998).
2.FDA, Non-Inferiority Clinical Trials to Establish Effectiveness Guidance for Industry(November2016).
3.FDA,Brochure:The History of Drug Regulation in the United States, 1848: Imported Drugs, ch.1378, 32 Stat. 728 (1902).
4.FDA, What We Do,History,Milestones in Food and Drug Law History,
5.Carol Ballentine, Taste of Raspberries, Taste of Death,The 1937 Elixir Sulfanilamide Incident, FDA Consumer magazine(June 1981 Issue).
6.FDA, Does the FDA control advertisements for all drugs?
7.FDA, Investigational New Drug (IND) Application.
8.FDA, Treatment Use of Investigational Drugs - Information Sheet.
9.FDA, Reports of Information for Drug Effectiveness, 31 FEDERAL REGISTER 31,9426(31 Fed. Reg. 9426)(JULY 9, 1966).
10.FDA, CPG Sec. 440.100,450.200,450.300,Marketed New Drugs Without Approved NDAs and ANDAs Guidance for FDA Staff and Industry, Appendix Brief History of FDA Marketing Approval Requirements and Categories of Drugs That Lack Required FDA Approval., P8-9.
11.FDA, Regulatory Procedures Manual APRIL 2019 – Chapter 7: RECALL PROCEDURES, 7-5-2 FDA Requested Recall, P12(April 2019).
【Chapter 3】
1.FDA, Reports of Information for Drug Effectiveness, 31 FEDERAL REGISTER v 31,9426(31 Fed. Reg. 9426)(JULY 9, 1966).
2.FDA, Guidance for Industry-Providing Clinical Evidence of Effectiveness for Human Drugs and Biological Products, Pp 1-2 (May 1998).
3.FDA, Guidance for Industry Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions,Ⅲ. G., p6(2002).
4.FDA, Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (December 2009).
5.FDA, E3 Guideline for Industry Structure and Content of Clinical Study Reports(2013).
6.FDA, Non-Inferiority Clinical Trials to Establish Effectiveness Guidance for Industry(November 2016).
【Chapter 4】
1.CTR, For Drug Evaluation & Research & CTR. For Biologics Evaluation & Research, FDA, Guidance For Industry:Format And Content Of Proposed Risk Evaluation And Mitigation Strategies (REMS), REMS Assessments, And Proposed REMS Modifications(2009).
2.FDA, Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products. (“Physician Labeling Rule”(PLR)), 71(15)Federal Register 3921- 3997(January 24, 2006).
3.FDA Adverse Event Reporting System (FAERS) (Formerly AERS)(last updated May.10, 2019).
4.FDA, Draft Guidance, Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices, at 2–3 (quoting 21 U.S.C.§352(f))(2009)
5.FDA, Final Guidance on Industry-Supported Scientific and Educational Activities, 62Fed.Reg. 64,074, 64,076-79 (Dec. 3,1997).
6.FDA, Legal Status Of Approved Labeling For Prescription Drugs; Prescribing For Uses Unapproved By The Food And Drug Administration, 37(158) Fed.Reg. 16503,16504.( Aug.15, 1972)
7.FDA, Labeling For Prescription Drugs Used In Man, Proposed Format for Prescription-Drug Advertisements, 40(67)Fed. Reg., 15392, 15392.(Apr. 7, 1975)
8.FDA, Notice, Prescription Drug User Fee Rates for Fiscal Year 2014, 78 (149) Fed.Reg. 46,980, 46,984 table7.(Aug.2,2013)
9.FDA, Guidance to Industry on Dissemination of Reprints of Certain Published, Original Data(1996).
10.FDA, Advertising and Promotion; Guidances, 61 Fed. Reg. at 52,800. Ibid. at 52801.
11.FDA, Guidance for Industry Funded Dissemination of Reference Texts(1996).
12.FDA, Guidance for Industry Industry-Supported Scientific and Educational Activities.,62 Fed. Reg. at 64,094. Ibid.,at p1.
13.FDA , Notice, 65(52) Fed. Reg. 14286(March 16, 2000).
14.FDA, Guidance for Industry: Industry-Supported Scientific and Educational Activities(1997).
15.FDA , Adancing Regulatory Science At FDA(2011).
16.FDA, Legal Status Of Approved Labeling For Prescription Drugs; Prescribing For Uses Unapproved By The Food And Drug Administration, 37(158) Fed.Reg. 16503,16504(Aug.15, 1972).
17.FDA, Final Amended Order Granting Summary Judgment and Permanent Injunction, 64 F.R. 44025(Aug.12,1992).
18.FDA, Notice, Decision in Washington Legal Foundation v. Henney, 65 Federal Register 14286(March 16, 2000).
19.FDA, Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices
20.Food Drug Cos.L.(S.D.Fla. 1974) Rep. 38,009 at 38,035(2009 Jan.).
21.GAO.,Off-Label Drugs : Reimbursement Policies Constrain Physicians in Their Choice of Cancer Therapies, GAO/PEMD-91-14 (Washington, D.C.: Sept. 27, 1991).
22.GAO, Presription Drugs: FDA’s Oversight of the Promotion of Drugs for Off-Label Uses, P1(July 28, 2008), this report quoted from D.C. Radley, S.N. Finkelstein, and R.S. Stafford,“Off-Label Prescribing Among Office-Based Physicians,”Archives of Internal Medicine, vol. 166, no. 9 .(2006)
23.Guidance to Industry on Dissemination of Reprints of Certain Published , Original Data and Guidance for Industry Funded Dissemination of Reference Texts, 61 Fed.Reg. 52,800(1996).
24.Guidance for Industry: Industry-Supported Scientific and Educational Activities , 62 Fed.Reg. 64,093, 64,096-99(1997).
25.Proposed New Drug, Antibiotic, and Biologic Drug Product Regulations, 48 Fed. Reg. 26720, 26733 (1983).
26.See & Food Labeling; General Requirements for Health Claims for Food ., 58 Fed.Reg. 2478, 2525(1993).
27.59 Fed. Reg. 59280, 59281.
28.61 Fed.Reg. 52800 (Oct. 8, 1996).
29.62 Fed. Reg. at 64079.(December 3, 1997).
【Chapter 5】
1.Department of Justice（DOJ）, FACT SHEET SIGNIFICANT FALSE CLAIMS ACT SETTLEMENTS & JUDGMENTS FISCAL YEARS 2009-2016.
2.The Department of Health and Human Services and The Department of Justice, Health Care Fraud and Abuse Control Program Annual Report 2018.
3.Office of Inspector General, Compliance Program Guidance for Pharmaceutical Manufacturers(2003).
4.S.Rep. No. 99-345, at 9 , U.S.Code Cong. & Admin.News 1986, pp. 5266, 5274(1986).
F、European Union:
1.Directive 2001/83/EC, Article 8(3)(j).
2.European Commission, A Guideline on Summary of Product Characteristics (SmPC)(September 2009.).
3.Regulation (EC) 726/2004, Article 6(1).
G、TEXT BOOK:
【Chapter 1-2】
1.REMERS, EDWARD K , K EMERS AND URDANG’S HISTORY OF P HARMACY, at 216. ch. 70 (1848), 9 Stat. 237 (4th ed. 1976).
2.MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
3.Heath, Wesley J., America’s First Drug Regulation Regime: The Rise and Fall of the Import Drug Act of 1848, 59 FOOD & DRUG L.J. 169, 175 (2004).
【Chapter 5】
1.Baumann, Linda A., ed., Health Care Fraud and Abuse: Practical Perspectives 116 (ABA Health Law Section, 2002).
2.Wright, Charles Alan & Miller, Arthur R. (2nd ed.1990), Federal Practice and Procedure § 1298, at 625-26.
H、Paper:
【Chapter 1-2】
1.Cowen David L., The Development of State Pharmaceutical Law, PH, ARMACY IN HISTORY, Vol. 37 No. 2, at 54(1995).
2.Chhabra, Renu, Kremzner,Mary E, and Kiliany, Brenda J , FDA Policy on Unapproved Drug Products: Past, Present, and Future, 39 The Annals of Pharmacotherapy 1260, 1262(2005 July/August).
3.Janssen,Wallace F. , Outline of the History of U.S. Drug Regulation and Labeling, 36 FOOD DRUG COSM . L.J. 420, 425(1981).
4.Lebovitz, R., & Giffin, Y., R., Transforming Clinical Research in the United States:Challenges and Opportunities: Workshop Summary. Institute of Medicine of the National Academies, Forum on Drug Discovery, Development, and Translation Board on Health Sciences Policy. Washington, D.C.: The National Academies Press (2010).
5.McGrath, Sue, Only A Matter Of Time: Lessons Unlearned at the Food and Drug Administration Keep Americans at Risk, 60 FOOD & DRUG L.J. 603, 604 (2005).
6.Meadows, Michelle, Promoting Safe and Effective Drugs for 100 Years, part The First Federal Drug Law ,FDA Consumer magazine The Centennial Edition/January-February 2006(2006).
7.Sertkaya et al., Examination of Clinical Trial Costs and Barriers for Drug Development, at ix, 4-1( July 2014).
8.Tigerstrom , Barbara von, Revising the Regulation of Stem Cell-Based Therapies: Critical Assessment of Potential Models(2015).
【Chapter 3】
1.Begg Colin B.,Berlin Jesse A., Publication Bias: A Problem in nterpreting Medical Data, 151 J. ROYAL STAT. SOC’Y [SERIES A] 419, 421(1988).
2.Berlin Jesse A.et al., An Assessment of Publication Bias Using a Sample f Published Clinical Trials, 84 J. AM. STAT. ASS’N 381, 391(1989).
3.Carolyn J. Greene, Noninferiority and Equivalence Designs: Issues and Implications for Mental Health Research, 21(5) J Trauma Stress. 433, 434 .doi:10.1002/jts.20367(Oct 2008).
4.Chhabra R.,Kremzner Mary E, Kiliany Brenda J, FDA olicy on Unapproved Drug Products: Past, Present, and Future, 39 The Annals of Pharmacotherapy 1260, 1262(2005 July/August).
5.Cook Chad E., Clinimetrics Corner: The inimal Clinically Important Change Score (MCID): A Necessary Pretense, 16(4) J Man Manip Ther. E82–E83(online only)( Published online: 18 Jul 2013).
6.Cravens Sarah M.R., The Usage and Meaning of "Clinical Significance" in Drug-Related Litigation, 59(2) Washington and Lee Law Review 553, 554(2002).
7.Darrow , Jonathan J. Pharmaceutical Efficacy: The Illusory Legal tandard, 70(4) Washington and Lee Law Review 2073, 2076(2013).
8.Dunnett CW. , Gent M., Significance testing to establish
equivalence between treatments with special reference to data in the form of 2 × 2 tables. 33(4) Biometrics. 593-602.[PubMed: 588654](Dec.1977)
9.Garrett AD, Therapeutic equivalence:fallacies and falsification.,
Statistics in Medicine 741-762.[PubMed: 12587103].(2003)
10.Hajiro T., Nishimura K., Minimal clinically significant difference in Health status: The thorny path of health status measures? (2002)19(3) Eur Respir J.390–391.Enderson, Jennifer A., Smith, John J., Realizing the Potential for Biomarkers in Imaging: Background and Legal Basis, 60(4) FOOD AND DRUG LAW JOURNAL 511, 514 (2005).　
11.Jaeschke R., Singer J. , Guyatt Gordon H., Ascertaining the minimal clinically important difference. 10(4) Control Clin Trials 407-415(1989).
12.Katz Russell, FDA: Evidentiary Standards for Drug
Development and Approval, 1 NeuroRx 3, 307, 311.(PMCID: PMC534930; doi:10.1602/ neurorx.1.3.307) (Jul 2004)
13.Kazdin Alan E., The Meanings and Measurement of Clinical Significance, 67 Journal of Consulting and Clinical Psychology 3, 332, 332(June 1999).
14.Klasmeier, Coleen and Cope, Torrey, NDA Approval Under FDCA Section 505(b)(1) Based on Effectiveness Data from One Clinical Trial , P12 .(cletronic copy only)(January 10, 2012)
15.Ndrea C. Skelly, Probability, proof, and clinical significance, Evid Based Spine Care J. 4 , 9,10(2011 Nov).
16.Peck Carl C., Wechsler Jill, Report of a Workshop on Confirmatory Evidence to Support a Single Clinical Trial as a Basis for New Drug Approval, 36 Drug Information Journal 517, 520(2002).
17.Peterson, I., Publication Bias: Looking for Missing Data, SCI. NEWS, Jan. 7, 1989, at 5(1989) .
18.Peyrin-Biroulet Laurent, Lopez Anthony, Sandborn William, Head-to-head Comparative Studies: Challenges and Opportunities? , 11(2)Journal of Crohn's and Colitis, 2 (March 2017).
19.Schuirmann DJ., A comparison of the two one-sided tests procedure and the power approach for assessing equivalence of average bioavailability. 15(6) J. Pharmacokin Biopharm. 657–680(1987).
20.Sherman Rachel E. et al.., Real-World Evidence — What Is It and What Can It Tell Us?, 375(23) New England Journal of Medicine 2293,2293(December 8, 2016).
21.Tkins, David C. et al., Assessing clinical significance: Does it matter which method we use?, 73(5) Journal of Consulting and Clinical Psychology 982,982(2005).
22.Walker Esteban, Understanding Equivalence and Noninferiority Testing, 26(2) J Gen Intern Med.192,192(Feb. 2011).
【Chapter4】
1.Avorn, Jerry et al., "Scientific Versus Commercial Sources of Influence on the Prescribing Behavior of Physicians," 73 Am.J.Med. 4-8;Bowman&Pearle,at 13-20(1982).
2.Anita Bernstein, Voluntary Recalls, 2013(1) University of Chicago Legal Forum 359,364(2013).
3.Blackwell, Elizabeth,A & Beck, James M. , Drug Manufacturers’ First Amendment Right to Advertise and Promote Their Products for Off-Label Use: Avoiding a Pyrrhic Victory, 58 Food & Drug L.J. 439, 440(2003) .
4.Bero, Lisa et al. , The Publication of Sponsored.
5.Bowman, Marjorie A., The Impact of Drug Company Funding on the Content of Continuing Medical Education, 6 Mobius 66–69 (January 1986).
6.Bowman, Marjorie A. and Pearle,David L., "Changes in Drug Prescribing Patterns Related to Commercial Company Funding of Continuing Medical Education," 4 Journal of Continuing Education in the Health Professions 13, 13-20(1988).
7.Barlas, Stephen, Off-Label Drug Bills Back on Track But Democrats Could Run at Least One Off the Rails, 42(10) P. T. 603,651 ( 2017 Oct).
8.Curtiss FR, Fairman KA., Contradictory actions on off. label use of prescription drugs? The FDA and CMS versus the U. S. Justice Department. 15 J Manag Care Pharm. 161–5(2009) .
9.Cowen, David L., The Development of State Pharmaceutical Law, PHARMACY IN HISTORY, Vol. 37 No. 2, at 54(1995).
10.Conko, Gregory, Hidden Truth: The Perils and Protection of Off-Label Drug and Medical Device Promotion, 21 HEALTH MATRIX 149, 159-61 (2011).
11.Cohen, Thea, The First Amendment and the Regulation of Pharmaceutical Marketing: Challenges to the Constitutionality of the FDA’s Interpretation of the Food, Drug, and Cosmetics Act, 49 AM. CRIM. L. REV. 1945, 1967 (2012).
12.Dumarcet N, Emmerich J, A, Lorence . France's New Framework for Regulating Off-Label Drug Use. 367 N. Engl. J. Med. 1279–81(2012).
13.Devereux, Richard B. , Appetite Suppressants and Valvular Heart Disease, 339 N. Engl. J. Med.765-767(1998).
14.Emerson ,T. , The System of Freedom of Expression, at 6-7(1970).
15.Emerson, T. , The First Amendment Doctrine and The Burger Court, 68 Calif. L. Rev., 422, 423(1980).
16.Field, Robert I., The FDA’s New Guidance for Off-Label Promotion Is Only a Start, 33(4) P T. 220, 249 ( Apr. 2008).
17.Gupta,andeep Kumar and Nayak ,Roopa Prasad, Off-label use of medicine: Perspective of physicians, patients, pharmaceutical companies and regulatory authorities, 5(2) J Pharmacol Pharmacother 88,90 (April-June 2014).
18.Greene, Stephanie, Lars Noah , Debate , Off-Label Drug Promotion and the First Amendment, 162 U.PA. L. REV. ONLINE, 239, 240,242,248(2014).
19.Hanson, Robin , Warning Labels as Cheap-Talk: Why Regulators Ban Drugs, 87 J. PUB. ECON. 2013, 2014(2003).
20.Hill KP ,Ross JS et al., Guest authorship and ghostwriting in publications related to rofecoxib: a case study of industry documents from rofecoxib litigation. J Amer Med Assn.;299:1800–1812(2008).
21.JI, Sirven. New uses for older drugs: The tales of aspirin, thalidomide, and gabapentin. 85 Mayo Clin Proc. 508–11 (2010).
22.Klasmeier, Coleen & Redish, Martin H., Off-Label Prescription Advertising, the FDA and the First Amendment: A Study in the Values of Commercial Speech Protection, 37 AM. J.L. & MED. 315, 334,350(2011).
23.Kessler, D.A. , "Regulating the Prescribing of Human Drugs for Nonapproved Uses Under the Food, Drug, and Cosmetic Act," 15 Harv.J.Legis. 693, at 742, 747(1978) .
24.Kessler, David A.,et al., Therapeutic-Class Wars -- Drug Promotion in a Competitive Marketplace, 331 N Engl J Med 1350-1353(November 17, 1994).
25.KP,Hill et al.The ADVANTAGE seeding trial: a review of internal documents. 149 Ann Intern Med. 251–258(2008).
26.Kozinski & Banner, The Anti-History and Pre-History of Commercial Speech, 71 Texas L. Rev. 747(1993).
27.Lee, Susan, 21st Century Cures Offers More Latitude to Promote Health Care Economic Information, but Ambiguities Would Remain, posted in Pharmaceutical & Biotechnology ( DECEMBER 5TH, 2016).
28.Miller, Kathleen L. and Miller, Michael , Investigating the landscape of US orphan product approvals, 13 Orphanet J Rare Dis. 183(2018).
29.Noah, Lars , Constraints on the Off-Label Uses of Prescription Drug Products，16 J. PROD. &TOXICS LIAB. 139, 145 & n.26(1994).
30.Noa,Lars h & Noah, Barbara A., Liberating Commercial Speech: Product Labeling Controls and the First Amendment, 47 Fla.L.Rev. 63, 96(1995).
31.Noah, Lars, Truth or Consequences?: Commercial Free Speech vs. Public Health Promotion (at the FDA), 21 HEALTH MATRIX 31 (2011).
32.Netanel,Neil Weinstock, First Amendment Constraints on Copyright After Golan v. Holder, 60 UCLA L. REV. 1082, 1113 (2013).
33.Noble, Robert C. , Physicians and the Pharmaceutical Industry: An Alliance with Unhealthy Aspects, 36 Perspectives in Biology and Medicine 376–394(Spring 1993).
34.Obertson, Hristopher R , When Truth Cannot Be Presumed: The Regulation of Drug Promotion Under An Expanding First Amendment, 94 Boston University Law Review 545, 554,557,note 64-67;supra note 195 at 558,560-561,563,565-566,568-570(2014).
35.Osborn,John E., Can I Tell You the Truth? A Comparative Perspective on Regulating Off-Label Scientific and Medical Information, 10 YALE J. HEALTH POL’Y L. & ETHICS 299, 307 (2010).
36.Peirce ,Charles S., How to Make Our Ideas Clear, 12 POPULAR SCI. MONTHLY 286, 286-302 (1878) .
37.Polubinski III,Note,Edmund,Closing the Channels of Communication: A First Amendment Analysis of the FDA's Policy on Manufacturer Promotion of Off-Label Use, 83 Va.L.Rev. 991, 1031 (1997).
38.RS, Stafford . Regulating off-label drug use -- Rethinking the role of the FDA. 358 N Engl J Med. 1427-1429(2008).
39.Tabarrok,Alexander T., Assessing the FDA via the Anomaly of Off-Label Drug Prescribing, v.V n.1 Independent Review 25,27,34,38(Summer 2000).
40.Toulmin, H. A., Jr., A Treatise on the Law of Foods, Drugs Cosmetics § 24.12 at 576 (2d ed. 1963).
41.Zacherle, Emily , AMCP Partnership Forum: FDAMA Section 114—Improving the Exchange of Health Care Economic Data ,22 (7)Journal of Managed Care & Specialty Pharmacy(JMCP) 826, 826.(July 2016)
【Chapter 5】
1.Androphy, Joel M. & Correro, Mark A., Whistleblower and Federal Qui Tam Litigation-Suing the Corporation for Fraud, 45 S.Tex. L. Rev. 23, 26,36,37,39,45-46. (Winter 2003).
2.Alperowicz, M, A Case at a Crossroad: United States ex rel. Franklin v. Parke-Davis and the Intersection of Regulating Promotion of Off-Label Uses and Medicaid Fraud and Abuse, HLS Student Papers,Pp32-34,esp. note109.
3.Bauer, Lane D. and Stith, Laura D., The Duty to Warn, in Donald E. Vinson and Alexander H. Slaughter, eds, Products Liability: Pharmaceutical Drug Cases 120, 149-52 (McGraw-Hill 1988).
4.Bucy, Pamela H. , Growing Pains: Using the False Claims Act to Combat Health Care Fraud, 51 Ala. L. Rev. 57, 88(1999).
5.Dixon, Marden G., 2 Drug Product Liability § 14.01 at 14-3 (Matthew Bender 1994).
6.Krause, Joan H., “Promises to Keep”: Health Care Providers and the Civil False Claims Act, 23 Cardozo L. Rev. 1363, 1367-68 (March 2002).
7.Krause, Joan H., Health Care Providers and the Public Fisc: Paradigms of Government Harm Under the Civil False Claims Act, 36 Ga. L. Rev. 121, 134.supra note 14, at 140 (Fall 2001).
8.Munich, John & Lane, Elizabeth Lane, When Neglect Becomes Fraud: Quality of Care and False Claims, 43 ST. LOUIS U. L.J. 27, 30–31,36-37(1999).
9.Owen, David G., Special Defenses in Modern Products Liability Law, 70 MO. L. REV. 1, 2-3 .supra note 85 , at p2-7,p12-14 (2005).
10.Struve,Catherine T., The FDA and the Tort System: Postmarketing Surveillance, Compensation, and the Role of Litigation, 5 Yale J. Health Pol'y, L. & Ethics 587, p1(2005).
11.Sheehan, James G. Sheehan , Health Care Fraud and Abuse: Practical Perspectives, 24(1) Journal of Legal Medicine 135-139,152(Jan., 2003).
12.Stoffelmayrt, Kaspar J., Products Liability and "Off-Label" Uses of Prescription Drugs, 63 University of Chicago Law Review 275, 288,292 (1996).