The Safety and Effectiveness of New Drugs (standards for Evaluating Drug Effectiveness--enforcement Problems).: Hearing Before a Subcommittee of the Committee on Government Operations, House of Representatives, Ninety-second Congress, First Session. May 5, 1971, Volumes 74-77 |
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Common terms and phrases
30 days Abbott Laboratories Academy of Sciences-National acetaminophen action adequate and well-controlled Agency Alevaire announcement antacid antitussive basis BROWN Bureau of Drugs Chairman Chlortetracycline chlorzoxazone claims of effectiveness codeine Commissioner of Food committee conclusions criteria dextromethorphan district court Drug Administration Drug Efficacy Study EDWARDS Efficacy Study Group Efficacy Study Implementation evidence of effectiveness Federal Food Federal Register Food and Drug FOUNTAIN FUQUA genuine and substantial GOLDHAMMER GOODRICH GUY VANDER JAGT industry ineffective injunction issue of fact JENNINGS labeling lack of substantial level of cyclamate Lutrexin lututrin manufacturer McNeil Laboratories medical documentation National Academy new-drug applications OTC drugs over-the-counter drugs Parafon Forte possibly effective prescription drugs procedures published question recognized as safe record regulations request Sciences-National Research Council scientific September September 16 sound documentation subcommittee submitted substantial evidence substantial issue TETRACYCLINE tion well-controlled clinical investigations Winthrop Products withdraw approval
Popular passages
Page 23 - 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 22 - A request for a hearing may not rest upon mere allegations or denials, but must set forth specific facts showing that there is a genuine and substantial issue of fact that requires a hearing.
Page 21 - Uncontrolled studies or partially controlled studies are not acceptable as the sole basis for the approval of claims of effectiveness. Such studies, carefully conducted and documented, may provide corroborative support of well-controlled studies regarding efficacy and may yield valuable data regarding safety of the test drug.
Page 28 - Signature : (Hospital Official)" Interested persons may, within 90 days after publication hereof in the FEDERAL REGISTER, file with the Hearing Clerk, Department of Health, Education, and Welfare, Room 6-88, 5600 Fishers Lane, Rockville, MD 20852.
Page 25 - The existence of a difference of opinion, among experts qualified by scientific training and experience, as to the truth of a representation made or suggested in the labeling is a fact (among other facts) the failure to reveal which may render the labeling misleading, if there is a material weight of opinion contrary to such representation.
Page 26 - ... qualification is not necessary. When the Food and Drug Administration classification of the claim, as stated in the implementation notice, differs from that of the Academy but is other than "effective," the qualifying statement shall refer to this classification in lieu of the Academy's classification. (d) For new drugs and antibiotics, supplements to provide for revised labeling in accord with paragraph (c) of this section shall be submitted under the provisions of...
Page 20 - Administration with respect to such drug, there is lack of substantial evidence consisting of adequate and well-controlled investigations, including clinical (field) investigation, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved...
Page 18 - TITLE 21— FOOD AND DRUGS CHAPTER I — FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE SUBCHAPTER...
Page 26 - Academy classification of a drug as other than "effective" for a claim for which such drug is recommended establishes that there is a material weight of opinion among qualified experts contrary to the representation made or suggested in the labeling, and failure to reveal this fact causes such labeling to be misleading. (c) Therefore, after publication in the FEDERAL REGISTER of a Drug Efficacy Study Implementation notice on a prescription drug, unless exempted or otherwise provided for in the notice,...
Page 21 - In certain circumstances, such as those involving diseases with high and predictable mortality (acute leukemia of childhood) , with signs and symptoms of predictable duration or severity (fever in certain infections), or in case of prophylaxis, where morbidity is predictable, the results of use of a new drug entity may be compared quantitatively with prior experience historically derived from the adequately documented natural history of the disease or condition in comparable patients or populations...