The Pharmaceutical Industry: Access and Outlook

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Nova Publishers, 2002 - 193페이지
Politicians consistently wage high-profile battles over prescription drugs and the companies that make them. The dilemma is balancing the pharmaceutical industry's need to make a profit with the public's need for affordable medical care. This book presents analyses of the federal government's regulation of the drug industry and the arguments over the prices of prescription drugs.

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Drug Regulation Historical Overview and Current Reform Proposals
1
Prescription Drugs Pricing Differences between Insured and Uninsured Consumers
23
Prescription Drugs Factors Influencing Their Pricing
35
Prescription Drug Price Comparisons The United States Canada and Mexico
45
Prescription Drugs Importation for Personal Use
51
Prescription Drug Prices The Effects of Generics Formularies and Other Market Changes
59
Outpatient Prescription Drugs Acquisition and Reimbursement Policies under Selected Federal Programs
65
The US Drug Approval Process A Primer
71
Health Care Reform and Investment in New Drug Development
113
Drug Prices and the CPI
137
GATT and the Pharmaceutical Industry Prospective Effects of the Uruguay Round on the Industry
141
Background
147
Growth in RD Investment
151
Discovery and Development
157
Pharmaceutical Expenditures in Perspective
171
The Growth of Managed Care
181

Pharmaceutical Research and Development A Description and Analysis of the Process
87

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3 페이지 - Formulary, or any supplement to any of them ; and (2) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (3) articles (other than food) intended to affect the structure or any function of the body of man or other animals...
74 페이지 - drug," as used in this Act, shall include all medicines and preparations recognized in the United States Pharmacopoeia or National Formulary for internal or external use, and any substance or mixture of substances intended to be used for the cure, mitigation, or prevention of disease of either man or other animals. The term "food...
4 페이지 - As used in this subsection and subsection (e), 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,...
4 페이지 - Unless its labeling bears (1) adequate directions for use; and (2) such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users...
4 페이지 - labeling" means all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.
75 페이지 - Secretary pursuant to subsection (b), do not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof...
81 페이지 - ... the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action.
72 페이지 - Congressional enactment of the Drug Price Competition and Patent Term Restoration Act of 1984 (PL 98-417).
74 페이지 - drug' means (1) articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them...
4 페이지 - If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of...

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