Use of Advisory Committees by the Food and Drug Administration: Hearings Before a Subcommittee of the Committee on Government Operations, House of Representatives, Ninety-third Congress, Second Session ...

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Page 59 - 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 under the conditions prescribed, recommended, or suggested in the proposed labeling...
Page 477 - For the purpose of this subchapter — (1) ' agency" means each authority of the Government of the United States, whether or not it is within or subject to review by another agency, but does not include — (A) the Congress; (B) the courts of the United States; (C) the governments of the territories or possessions of the United States; (D) the Government of the District of Columbia...
Page vi - FEDERAL ADVISORY COMMITTEE ACT FEDERAL ADVISORY COMMITTEE ACT PUBLIC LAW 92-463 AN ACT To authorize the establishment of a system governing the creation and operation of advisory committees in the executive branch of the Federal Government, and for other purposes.
Page 483 - Executive order; (2) related solely to the internal personnel rules and practices of an agency; (3) specifically exempted from disclosure by statute; (4) trade secrets and commercial or financial information obtained from a person and privileged or confidential...
Page 476 - Presidential advisory committee" means an advisory committee which advises the President. APPLICABILITY SEC. 4. (a) The provisions of this Act or of any rule, order, or regulation promulgated under this Act shall apply to each advisory committee except to the extent that any Act of Congress establishing any such advisory committee specifically provides otherwise.
Page 172 - Code, the records, reports, transcripts, minutes, appendixes, working papers, drafts, studies, agenda, or other documents which were made available to or prepared for or by each advisory committee...
Page 75 - Detailed minutes of each meeting of each advisory committee shall be kept and shall contain a record of the persons present, a complete and accurate description of matters discussed and conclusions reached, and copies of all reports received, issued, or approved by the advisory committee.
Page 59 - 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 evaulate 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 240 - Records and reports concerning experience on drugs for which an approval is in effect. (a) On receiving notification that an application for a new drug is approved, the applicant shall establish and maintain records and make reports that are necessary to facilitate a determination whether there may be grounds for invoking section...
Page 240 - ... when the application was approved, the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of...

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