Law, Medicine and Medical Technology

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ISBN: 9781587781698 | 1587781697
Cover: Hardcover
Copyright: 11/1/2002

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Univ. of Florida, Gainesville. Text cites legal cases focusing on the control of medical technologies. Addresses controls mediating the creation and use of medical technology through systems of tort law, insurance, and intellectual regimes. Discusses FDA control, experimental therapies, product liability, and pricing and payment systems. For students.

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Preface	p. v
Acknowledgements	p. ix
Table of Cases	p. xxv
Government Regulation	p. 1
FDA Control: Preliminaries	p. 2
History and Overview	p. 2
Product Categories and Intended Use	p. 6
Adulteration, Misbranding, and the Practice of Medicine	p. 51
FDA Practice and Procedures	p. 70
Other Actors	p. 110
Development and Testing of Experimental Therapies	p. 137
Drug Discovery and Testing	p. 137
Institutional Review Boards	p. 153
Securing Informed Consent	p. 162
Access to Experimental Products	p. 183
Premarket Approval and Postmarket Surveillance	p. 198
Pharmaceutical Products	p. 198
Medical Devices	p. 230
Postmarket Surveillance Systems	p. 255
The Perils of Bad Regulatory Advice	p. 275
Dissemination of Product Information	p. 293
Labeling	p. 293
Advertising	p. 329
First Amendment Constraints on Regulating Information	p. 357
Tort Liability	p. 391
Products Liability: Preliminaries	p. 392
Strict Liability and Unavoidably Unsafe Products	p. 392
The Relationship to Regulatory Standards	p. 407
Causation Difficulties	p. 450
Production Failures	p. 481
Manufacturing Defects	p. 481
Design Defects	p. 488
Fear of Malfunction	p. 514
Informational Defects	p. 523
Triggering the Duty to Warn	p. 523
Scope of the Duty to Warn	p. 558
Measuring the Adequacy of Warnings	p. 579
Utilization Errors and Medical Malpractice	p. 597
Liability of Users and Prescribers	p. 598
Liability of Suppliers and Dispensers	p. 613
Economics and Innovation	p. 635
Pricing and Payment Systems	p. 636
Public Insurance	p. 637
Private Payers	p. 674
Technology Assessment and Outcomes Research	p. 694
Drug Pricing and Price Controls	p. 714
Managing Incentives for Innovation	p. 738
Intellectual Property Protections	p. 738
Market Exclusivity Periods	p. 802
Competition and Antitrust Law	p. 833
Evolving Medical Technologies	p. 859
Manipulation of Human Tissue Products	p. 859
The Human Genome Project and Its Technological Progeny	p. 902
Bioethical Challenges Posed by Medical Technology	p. 922
Statutory Appendix	p. 953
Index	p. 1151
Table of Contents provided by Ingram. All Rights Reserved.

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Law, Medicine and Medical Technology

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