Food, Drug, and Cosmetic Act Amendments of 1977: Hearings Before the Subcommittee on Health and Scientific Research of the Committee on Human Resources, United States Senate, Ninety-fifth Congress, First Session, on S. 1831 ... and Related Bills, July 26 and 27, 1977U.S. Government Printing Office, 1978 - 767 pages |
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95TH CONGRESS adverse drug reactions adverse reactions advertising advisory agency amended American application appropriate approval authority believe bill bioavailability brand Center Chairman chemical Clinical Pharmacology clinical pharmacy Commissioner Committee compendium consumer Cosmetic Act cost digitalis digitoxin digoxin distribution diuretic doctor Drug Administration Drug Board drug products Drug Science Board drug therapy established evaluation Federal Food Food and Drug Formulary functions Hospital investigations July 27 labeling legislation medicine ment National Drug Science NDSB patient package inserts penicillin person pharmacists Phase Phase IV physician potassium practicing physician practitioners prednisone prescribing prescription drugs present problem professional proposed record regulations require responsible safety sample San Joaquin SCHWEIKER scientific Secretary Section 502 Senator KENNEDY Senator SCHWEIKER specific standards statement studies Subcommittee testimony testing thereof tion United United States Code
Popular passages
Page 121 - ... 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; (2) the results of such tests show that such drug is unsafe for use under such conditions...
Page 467 - No. 5. If confirmed, are there any issues from which you may have to recuse or disqualify yourself because of a conflict of interest or the appearance of a conflict of interest?
Page 125 - That no additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal...
Page 657 - The community is concerned with the maintenance of professional standards which will insure not only competency in individual practitioners, but protection against those who would prey upon a public peculiarly susceptible to imposition through alluring promises of physical relief.
Page 118 - Treasury a loan guarantee and interest subsidy fund (hereinafter in this subsection referred to as the ''fund") which shall be available to the Secretary without fiscal year limitation, in such amounts as may be specified from time to time in...
Page 636 - Labeling shall be clear and truthful in all respects and may not be false or misleading in any particular. It shall state the intended uses and results of the product; adequate directions for proper use; and warnings against unsafe use, side effects, and adverse reactions in such terms as to render them likely to be read and understood by the ordinary individual, including individuals of low comprehension, under customary conditions of purchase and use.
Page 25 - Secretary finds (1) that clinical or other experience, tests, or other scientific data show that such drug is unsafe for use under the conditions of use upon the basis of which the application was approved...
Page 25 - 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,...
Page 482 - Any drug dispensed by filling or refilling a written or oral prescription of a practitioner licensed by law to administer such drug shall be exempt from the requirements of...
Page 77 - RIBICOFF) introduced the following bill; which was read twice and referred to the Committee on Labor and Public Welfare A BILL To amend the Federal Food, Drug, and Cosmetic Act to prohibit the administration of the drug diethylstilbestrol (DES) to any animal intended for use as food, and for other purposes.