Drug Safety: Hearings Before a Subcommittee of the Committee on Government Operations, House of Representatives, Eighty-eighth Congress, Second Session [Eighty-ninth Congress, Second Session].U.S. Government Printing Office, 1964 - 2377 pages |
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activities additional adequate adverse drug reactions adverse reactions advertisement agency American Medical Association animal tests animals antibiotic approved batch Chairman chemical chloramphenicol clinical investigations Commissioner of Food committee compounds concerning contraindications Cosmetic Act Department of Health disease dosage form Drug Administration Drug Amendments drug application drug safety Education established name evaluation exemption experience facilities FDA's Federal Food Federal Register Food and Drug FOUNTAIN GOLDBERG Government GRAY hearing examiner hospitals HUSSEY industry ingredient inspection Institute investigational drugs labeling laboratory LARRICK manufacturer manufacturing practice ment metabolism MIDER National new-drug application operations package Packaging and labeling patients pharmaceutical pharmacology physicians prescription drug procedures processing proprietary name records reports responsible safe samples scientific scientists side effects specific sponsor staff Stat statement studies subcommittee submitted substance supplemental application tests therapeutic tion toxicity Welfare
Popular passages
Page 79 - If a party objects to the admission or rejection of any evidence or to the limitation of the scope of any examination or cross-examination, he shall state briefly the grounds of such objection, whereupon an automatic exception will follow if the objection is overruled by the presiding officer. The transcrIpt shall not Include argument or debate thereon, except as ordered by the presiding officer.
Page 636 - ... 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, or suggested in the labeling or proposed labeling thereof.
Page 35 - ... 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 113 - A supplemental application should be submitted for any change beyond the variations provided for in the application (including changes in the scale of production, such as from pilot-plant to production batch), that may alter the conditions of use, the labeling, the safety, effectiveness, identity, strength, quality, or purity of the drug or the adequacy of the manufacturing methods, facilities, or controls to preserve them.
Page 80 - ... when the application was approved, the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of...
Page 572 - Secretary finds (1) that clinical or other experience, tests, or other scientific data show that such drug is unsafe for use under the conditions of use upon the basis of which the application was approved...
Page 137 - In the antibiotic regulations, this information shall be submitted as soon as the review reveals such facts. Any unresolved experience of the kinds listed in this paragraph shall be reported even though It occurred prior to the 2-year period. (c) Such reports shall be addressed to the Secretary, Department of Health, Education, and Welfare for the Commissioner of Food and Drugs, Washington, DC, 20204, and shall be distinctly marked "New Drug (or Antibiotic) Report," together with the applicable new...
Page 119 - ... drug, based on a fair evaluation of all material facts, is false or misleading in any particular and...
Page 69 - Secretary pursuant to subsection (b), do not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use...
Page 121 - ... when the agency for good cause finds (and incorporates the finding and a brief statement of reasons therefor in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.