Use of Advisory Committees by the Food and Drug Administration: Hearings Before a Subcommittee of the Committee on Government Operations, House of Representatives, Ninety-third Congress, Second Session ...U.S. Government Printing Office, 1974 |
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acid indigestion action active ingredients Advisory Committee agency Alka-Seltzer aluminum analgesic antacid antacid products aspirin bleeding Chairman chronic claims combination Commissioner consumer containing zirconium Cosmetic court December 22 decision discussion document dosage dose draft report DRINAN Drug Administration drug application drug products Evans evidence experts FDA's Federal Register Food and Drug FOUNTAIN gastric GOLDBERG GOLDHAMMER granuloma haematemesis heartburn hexachlorophene HUTT indications industry Ingelfinger inhalation issue labeling laxative litigation lung meeting Miles Laboratories monograph NDA's OTC antacid OTC drug review OTC review over-the-counter drugs Panel concludes panel member Panel on review particles patients peptic ulcer podophyllum procedure Procter & Gamble question recognized as safe recommendation regulations review panel safe and effective safety SCHMIDT scientific Shefter Simethicone sodium zirconium lactate statement studies submitted symptoms tablets toxicity upset stomach Yingling zirconium chlorhydrate zirconium-aluminum-glycine complex zirconium-containing aerosol antiperspirants
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Страница 328 - Court in applying the doctrine of primary jurisdiction stated: "[It is] now firmly established, that in cases raising issues of fact not within the conventional experience of judges or cases requiring the exercise of administrative discretion, agencies created by Congress for regulating the subject matter should not be passed over.
Страница 8 - Procedures 330.10 Procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded, and for establishing monographs.
Страница 323 - But the liberty safeguarded is liberty in a social organization which requires the protection of law against the evils which menace the health, safety, morals, and welfare of the people. Liberty under the Constitution is thus necessarily subject to the restraints of due process, and regulation which is reasonable in relation to its subject and is adopted in the interests of the community is due process.
Страница 266 - Effectiveness means a reasonable expectation that, in a significant proportion of the target population, the pharmacological effect of the drug, when used under adequate directions for use and warnings against unsafe use, will provide clinically significant relief of the type claimed.
Страница 358 - Register, file with the Hearing Clerk, Department of Health, Education, and Welfare, Room 6-88, 5600 Fishers Lane. Rockville, Md. 20852, written comments (preferably in quintuplicate) regarding this proposal.
Страница 7 - An over-the-counter (OTC) drug listed In this subchapter is generally recognized as safe and effective and is not misbranded If It meets each of the conditions contained in this part and each of the conditions contained in any applicable monograph. Any product which falls to conform to each of the conditions contained in this part and 21 CFR Ch.
Страница 266 - Proof of effectiveness shall consist of controlled clinical investigations as defined In § 314.111(a)(5)(Ii) of this chapter, unless this requirement is waived on the basis of a showing that It Is not reasonably applicable to the drug or essential to the validity of the Investigation and that an alternative method of investigation is adequate to substantiate effectiveness.
Страница 45 - new drug" means — (1) Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof, except that such a drug not so recognized shall not be deemed to be a "new drug...
Страница 89 - Chairman, Subcommittee on Intergovernmental Relations and Human Resources, Committee on Government Operations, House of Representatives, Washington, DC DEAR MR.
Страница 11 - After reviewing all comments, reply comments, and any new data and information, the Commissioner shall publish in the FEDERAL REGISTER a tentative order containing a monograph establishing conditions under which a category of OTC drugs is generally recognized as safe and effective and not misbranded. Within...