Code of Federal Regulations: Containing a Codification of Documents of General Applicability and Future Effect as of December 31, 1948, with Ancillaries and Index

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Division of the Federal Register, the National Archives, 1964
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Página 567 - 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,...
Página 6 - The article comprising each shipment or other delivery hereafter made by (name of person giving the guaranty or undertaking) to, or on the order of (name and post-office address of person to whom the guaranty or undertaking is given) is hereby guaranteed.
Página 559 - The newness of a drug may arise by reason (among other reasons) of: (1) The newness for drug use of any substance which composes such drug, in whole or in part, whether it be an active substance or a menstruum, excipient, carrier, coating, or other component. (2) The newness for drug use of a combination of two or more substances, none of which is a new drug. (3) The newness for drug use of the proportion of a substance in a combination, even though such combination containing such substance in other...
Página 573 - Evaluated on the basis of Information submitted as part of the application and any other information before the Food and Drug Administration with respect to such drug, there Is lack of substantial evidence consisting of adequate and well-controlled Investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness...
Página 561 - ... of any and all discernible effects attributable to the drug in each individual treated, and comparable records on any individuals employed as controls. These records shall be individual records for each subject maintained to include adequate information pertaining to each, including age, sex, conditions treated, dosage, frequency of administration of the drug, results of all relevant clinical observations and laboratory examinations made, adequate information concerning any other treatment given...
Página 382 - Substances that are generally recognized as safe. (a) It Is impracticable to list all substances that are generally recognized as safe for their intended use. However, by way of illustration, the Commissioner regards such common food ingredients as salt, pepper, sugar, vinegar, baking powder, and monosodium glutamate as safe for their intended use.
Página 31 - ... will not be adulterated or misbranded within the meaning of the Act upon completion of such processing, labeling, or repacking. Such person and such operator, shall each keep a copy of such agreement until 2 years after the final shipment or delivery of such...
Página 382 - ... not Intended to accomplish any physical or other technical effect in the food itself, shall be reduced to the extent reasonably possible. (3) The substance is of appropriate food grade and is prepared and handled as a food ingredient. Upon request the Commissioner will offer an opinion, based on specifications and intended use, as to whether or not a particular grade or lot of the substance is of suitable purity for use in food and would generally be regarded as safe for the purpose Intended,...
Página 7 - Presentation of views under section 305 of the act shall be private and informal. The views presented shall be confined to matters relevant to the contemplated proceeding. Such views may be presented by letter or in person by the person to whom the notice was given, or by his representative. In case such person holds a guaranty or undertaking referred to in section 303 (c) (2) or (3) of the act applicable to the article on which such notice was based, such guaranty or undertaking, or a verified copy...
Página 250 - Any combination of two, three, four, or five of such fruits In which the weight of each Is not less than one-fifth of the weight of the combination; except that the weight of pineapple may be not less than onetenth of the weight of the combination.

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