FDA Papers, Volum 4U.S. Food and Drug Administration, 1970 |
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Side 36
... directions for use . New drug ( s ) not approved for safety and efficacy . " " " Below labeled potency ; not in ... directions for use for " allergic conditions " ; ( Tri Histin expectorant ) lacked " drowsiness " and " small children ...
... directions for use . New drug ( s ) not approved for safety and efficacy . " " " Below labeled potency ; not in ... directions for use for " allergic conditions " ; ( Tri Histin expectorant ) lacked " drowsiness " and " small children ...
Side 37
... directions for use ( Yodarsol and Fluxine ) ; false and misleading claims for treatment of uncomplicated hemorrhoids , minor engorgement of veins , and painful menstru- ation ( Fluxine ) . Inadequate directions for use ; inadequate ...
... directions for use ( Yodarsol and Fluxine ) ; false and misleading claims for treatment of uncomplicated hemorrhoids , minor engorgement of veins , and painful menstru- ation ( Fluxine ) . Inadequate directions for use ; inadequate ...
Side 39
... directions and did not comply with the Rx drug exemption requirement for disclosure of information ; and the article was dangerous to health when used with the frequency and duration prescribed in its labeling ; 502 ( a ) , 502 ( f ) ...
... directions and did not comply with the Rx drug exemption requirement for disclosure of information ; and the article was dangerous to health when used with the frequency and duration prescribed in its labeling ; 502 ( a ) , 502 ( f ) ...
Side
... directions for administration of drugs to infants and children are complicated by too little infor- mation on drug metabolism in the constantly changing growth pattern of the very young . A Conference on Pediatric Pharmacology was held ...
... directions for administration of drugs to infants and children are complicated by too little infor- mation on drug metabolism in the constantly changing growth pattern of the very young . A Conference on Pediatric Pharmacology was held ...
Side 36
... directions for use and adequate directions against mis- use , the drug chemical was detained as a new drug lacking an effective New Drug Application . This material appears to be identical to the raw ma- terial used in pangamic acid ...
... directions for use and adequate directions against mis- use , the drug chemical was detained as a new drug lacking an effective New Drug Application . This material appears to be identical to the raw ma- terial used in pangamic acid ...
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Populære avsnitt
Side 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...
Side 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...
Side 14 - If it contain any added poisonous or other added deleterious ingredient which may render such article injurious to health...
Side 14 - 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...
Side 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.
Side 22 - 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.
Side 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.
Side 28 - ... 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.
Side 28 - 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.