Use of Advisory Committees by the Food and Drug Administration: Hearings ... Ninety-third Congress Second Session [-Ninety-fourth Congress, First 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 granulomas haematemesis heartburn hexachlorophene HUTT indications 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 products containing 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 324 - 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 43 - new animal drug" means any drug intended for use for animals other than man, including any drug intended for use in animal feed but not including such animal feed — (1) 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...
Страница 319 - 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 354 - 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 87 - Chairman, Subcommittee on Intergovernmental Relations and Human Resources, Committee on Government Operations, House of Representatives, Washington, DC DEAR MR.
Страница 9 - After reviewing all comments and reply comments, 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...
Страница 355 - June 4, 1976 contain the neutralizing capacity of the product as calculated using the procedure set forth in § 331.26 expressed in terms of the dosage recommended per minimum time interval or, if the labeling recommends more than one dosage, in terms of the minimum dosage recommended per minimum time interval.
Страница 175 - In either event the orderly functioning of the process of review requires that the grounds upon which the administrative agency acted be clearly disclosed and adequately sustained.
Страница 9 - Any interested person may, within 60 days after publication of the proposed order in the FEDERAL REGISTER, file with the Hearing Clerk of the Food and Drug Administration written comments in quintuplicate.
Страница 8 - A summary of the data and views setting forth the medical rationale and purpose (or lack thereof) for the drug and its ingredients and the scientific basis (or lack thereof) for the conclusion that the drug and its ingredients have been proven safe and effective for the intended use. If there is an absence of controlled studies in the material submitted, an explanation as to why such studies are not • considered necessary must be included. VII. If the submission is by a manufacturer, a statement...