A Legislative History of the Federal Food, Drug, and Cosmetic Act and Its AmendmentsU.S. Department of Health, Education, and Welfare, Public Health Service, Food and Drug Administration, 1979 |
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Common terms and phrases
Abbott Laboratories acid action amines animals antibiotic approved arsanilic acid Association bladder BROWN Bureau of Drugs cancer carcinogenic cephalexin cephalosporin Chadduck Chairman claims clinical committee Compliance containing cyclamates correct cyclamate-containing drugs Dear Doctor diethylstilbestrol Director District Division of Drug dosage dose Drug Administration Drug Advertising drug application drug products EDWARDS effective efficacy estrogens evaluation FDA's Federal Register firm food additive Food and Drug FOUNTAIN Garamycin GOLDBERG GOLDHAMMER GOODRICH GRAS list hearing HOUWELING indicated industry infections inspection Keflex Laboratories letter Lilly March March 18 meat tenderizer medicated feed memorandum nitrosamines Office over-the-counter drugs package patients percent physician problem procedures promotional material question recall recommendations record regulations Regulatory request residues response safety samples Serentil SIMMONS Skinker sodium nitrite statement STETLER stilbestrol subcommittee substance Sucaryl survey sweeteners tion tissue toxicity tumors WODICKA YEUTTER
Popular passages
Page 521 - 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,...
Page 90 - In compliance with clause 3 of rule XIII of the Rules of the House of Representatives, changes in existing law made by the bill, as reported, are shown as follows...
Page 90 - Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (2) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (3) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (4) articles intended for use as a component of any article specified in clause (1), (2), or (3); but does not include devices or their components,...
Page 396 - While there is no evidence of a causal relationship between these changes and significant disturbance of cardiac rhythm, several sudden and unexpected deaths apparently due to cardiac arrest have occurred in patients showing characteristic electrocardiographic changes while taking the drug.
Page 520 - ... issue of fact which precludes the action taken on the proposal, eg, no adequate and wellcontrolled clinical investigations to support the claims of effectiveness have been identified, the Commissioner will enter an order on this data, making findings and conclusions on such data.
Page 88 - ... (5) In determining, for the purposes of this section, whether a proposed use of a food additive is safe, the Secretary shall consider among other relevant factors— (A) the probable consumption of the additive and of any substance formed in or on food because of the use of the additive; (B) the cumulative effect of such additive in the diet of man or animals, taking into account any chemically or pharmacologically related substance or substances in such diet...
Page 396 - Central Nervous System: Drowsiness, Parkinson's syndrome, dizziness. weakness, tremor, restlessness, ataxia, dystonia, rigidity, slurring, akathisia, motoric reactions (opisthotonos).
Page 572 - ... he shall submit to the Commissioner for advance approval a full statement describing the proposed change. In the case of a proposal to use revised labeling on or within the drug package or promotional labeling containing information for use of the drug that is not the same in language and emphasis as the approved labeling, the applicant shall submit specimens for advance approval. Advance approval is not required when pursuant to a published Federal Register notice implementing a...
Page 394 - Mellaril (thioridazine); these appear to be reversible and due to altered repolarization, not myocardial damage. While there is no evidence of a causal relationship between these changes and significant disturbance...
Page 665 - The intended uses of an article may change after it has been introduced into interstate commerce by its manufacturer. If, for example, a packer, distributor, or seller intends an article for different uses than those intended by the person from whom he received the drug, such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses.