Agriculture, Rural Development, and Related Agencies Appropriations for 1982: Hearings Before a Subcommitee of the Committee on Appropriations, House of Representatives, Ninety-sixth Congress, First Session, Volum 4,Del 1U.S. Government Printing Office, 1981 |
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action activities aflatoxin amended ampicillin analysis analyzed animal drugs appropriate approval benzodiazepines biological blood budget Bureau cancer carcinogen chemical cimetidine clinical Committee compliance Conduct CONGRESS THE LIBRARY consumer contain Continue studies cosmetic costs digoxin dispensers distribution distributors dose Drug Administration Drug Applications drug classes establish Estimated evaluation facilities FDA's Federal Register feed food additives Food and Drug Full-time Equivalent guideline patient package human implementation increase initial inspections investigations laboratory levels LIBRARY OF CONGRESS manufacturers medical devices methods methoxsalen monitoring NOVITCH orphan drugs patient labeling patient package inserts pesticide petition pharmacists pharmacy phenytoin potential PPIs prescription drug prescription drug products problems procedures proposed propoxyphene radiation regulations regulatory reports request residues response revised risk safe and effective safety samples scientific September 12 standards submitted testing thiazide tion toxicity Toxicology vaccines warfarin WHITTEN
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Side 94 - ... 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 proposed labeling...
Side 637 - Secretary's order. (i) The Secretary shall promulgate regulations for exempting from the operation of the foregoing subsections of this section drugs intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs.
Side 95 - A copy of such petition shall be forthwith transmitted by the clerk of the court to the Secretary, or any officer designated by him for that purpose, and thereupon the Secretary shall file in the court the record of the proceedings on which he based his order, as provided in section 2112 of title 28, United States Code.
Side 96 - ... (5) The judgment of the court affirming or setting aside, in whole or in part, any order under this section shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification as provided in section 1254 of title 28 of the United States Code.
Side 96 - If either party shall apply to the court for leave to adduce additional evidence, and shall show to the satisfaction of the court that such additional evidence is material and that there were reasonable grounds for failure to adduce such evidence in the...
Side 95 - That on the basis of new information before him evaluated together with the evidence before him when the application was approved, the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of such drug or animal feed are inadequate to assure and preserve its identity, strength, quality, and purity...
Side 96 - ... before the Secretary, the court may order such additional evidence to be taken before the Secretary and to be adduced upon a hearing in such manner and upon such terms and conditions as to the court may seem proper.
Side 93 - ... upon the basis of the information submitted to him as part of the application, or upon the basis of any other information before him with respect to such drug, he has insufficient information to determine whether such drug is safe for use under such conditions...
Side 97 - ... inform any human beings to whom such drugs, or any controls used in connection therewith, are being administered, or their representatives, that such drugs are being used for investigational purposes and will obtain the consent of such human beings...
Side 266 - Congress, to favor or oppose, by vote or otherwise, any legislation or appropriation by Congress, whether before or after the introduction of any bill or resolution proposing such legislation or appropriation; but this shall not prevent officers or employees of the United States or of its departments or agencies from communicating to Members of Congress on the request of any Member or to Congress, through the proper official channels, requests for legislation or appropriations which they deem necessary...