Drug Labeling In Developing Countries
Examines the status of drug labeling by 18 U.S.-based multinational pharmaceutical companies in developing countries (Brazil, Kenya, Panama and Thailand). Includes: codes of conduct and voluntary guidelines for pharmaceutical information, efforts to improve drug information in developing countries, drug registration in developing countries, and much more. References, index and illustrations.
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active ingredients adverse reactions advertising aminoglycoside anabolic steroids analgesic antibiotic antibiotic pi anticholinergic antihistamine approved associated Brazil Breast-Milk Substitutes ceutical clinical pharmacology clinical trials clioquinol codes of conduct combination contraindications corporations corticosteroid developing countries divergence drug labeling Drug Promotion Essential Drugs Ethical Criteria evidence Expert Review Group extraterritorial jurisdiction FCPA FDA-approved foreign subsidiaries IFPMA IFPMA Code indications international law IOCU Kenya list inactive ingredients management of overdose marketed medical importance standard ment MNCs monitoring monograph multinational off-label OTA evaluation OTA's Overall Score package inserts patients percent pharma pharmaceutical labeling Pharmaceutical Manufacturers physicians pregnancy prescribing guide entries prescribing information prescription drugs product document query score registration regulations risk sample side effects specific steroids Thailand tion tional treatment tricyclic antidepressant Type of drug U.S. companies U.S. Congress U.S. Government U.S. labeling Washington World Health Organization wp Insert
Page iv - NOTE: OTA appreciates and is grateful for the valuable assistance and thoughtful critiques provided by the advisory panel members. The panel does not, however, necessarily approve, disapprove, or endorse this report. OTA assumes full responsibility for the report and the accuracy of its contents.
Page 122 - President by section 203 may be exercised to deal with any unusual and extraordinary threat, which has its source in whole or substantial part outside the United States, to the national security, foreign policy, or economy of the United States, if the President declares a national emergency with respect to such threat.
Page 92 - If in package form, unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count: Provided, that under clause (2) of this paragraph reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Board.
Page 136 - Medical representatives must be adequately trained and possess sufficient medical and technical knowledge to present information on their company's products in an accurate and responsible manner.
Page 113 - ... the secondary organizations. Provide a list of all organizations included in such consolidations. (3) "Associated" foreign organization: The ownership of at least 10 percent but less than 25 percent of the voting securities of a corporation, or an equivalent interest in an unincorporated foreign organization, held directly by the reporter and its United States affiliates, shall constitute association with that organization for the purposes of these reports. Note that separate reports are required...
Page 161 - List includes only drugs that are of "utmost importance and are basic, indispensable and necessary for the health needs of the population.
Page 104 - In summary, they provided that two or more drugs may be combined in a single dosage form when each component makes a contribution to the claimed effects and the dosage of each component, amount, frequency, and duration is such that the combination is safe and effective for a significant patient population requiring such concurrency therapy as defined in the labeling for the drug.
Page 151 - ... employed here and in another empirical investigation of private investment by IMF staff economists (Greene and Villanueva, 1991). Figure 8.1 uses this data base to calculate regional trends in private and public investment from 1970 to 1987. Twelve countries are included in the regional total: Argentina, Bolivia, Brazil, Chile, Colombia, Costa Rica, Ecuador, Guatemala, Mexico, Peru, Uruguay, and Venezuela.
Page 195 - ... people's lives. The assessment of technology calls for exploration of the physical, biological, economic, social, and political impacts that can result from applications of scientific knowledge. OTA provides Congress with independent and timely information about the potential effects — both beneficial and harmful — of technological applications. Requests for studies are made by chairmen of standing committees of the House of Representatives or Senate; by the Technolog) Assessment Board, the...
Page 100 - ... and biological disposition of the drug in animals and, if known, in humans. (iv) A summary of information relating to safety and effectiveness in humans obtained from prior clinical studies. (Reprints of published articles on such studies may be appended when useful.) (v) A description of possible risks and side effects to be anticipated on the basis of prior experience with the drug under investigation or with related drugs, and of precautions or special monitoring to be done as part of the...