FDA Papers, Volume 4

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U.S. Food and Drug Administration, 1970

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Page 5 - ... (2) a pesticide chemical to the extent that it is intended for use or is used in the production, storage, or transportation of any raw agricultural commodity ; or (3...
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. Such studies will be considered on their merits in the light of the principles Usted here, with the exception of the requirement for the comparison of the treated subjects with...
Page 10 - ... a full list of the articles used as components of such drug; (3) a full statement of the composition of such drug; (4) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug...
Page 22 - If it contain any added poisonous or other added deleterious ingredient which may render such article injurious to health...
Page 22 - An act for preventing the manufacture, sale, or transportation of adulterated or misbranded, or poisonous, or deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein, and for other purposes...
Page 5 - pesticide chemical" means any substance which, alone, in chemical combination or in formulation with one or more other substances, is an "economic poison" within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act (7 USC, sees.
Page 32 - The nutritional statements made in this advertisement have been reviewed by the Council on Foods and Nutrition of the American Medical Association and found consistent with current authoritative medical opinion.
Page 21 - Active treatment control: An effective regimen of therapy may be used for comparison, eg, where the condition treated is such that no treatment or administration of a placebo would be contrary to the interest of the patient.
Page 38 - ... shall con-form, as nearly as may be, to the procedure in admiralty; except that on demand of either party any issue of fact joined in any such case shall be tried by jury.
Page 38 - If it is dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof.

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