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 ...U.S. Government Printing Office, 1974 - Citizens' advisory committees in science |
From inside the book
Results 1-5 of 100
Page iv
... angina pectoris .. April 19 , 1974 , FDA memorandum regarding Depo - Provera , clarification of recall status_ 277-278 447-44 338-339 112-114 450-452 Article from the January 1974 issue of Family Planning Digest entitled " FDA OK's ...
... angina pectoris .. April 19 , 1974 , FDA memorandum regarding Depo - Provera , clarification of recall status_ 277-278 447-44 338-339 112-114 450-452 Article from the January 1974 issue of Family Planning Digest entitled " FDA OK's ...
Page vi
... angina pectoris - Memorandum by Dr. Crout , re approval of propranolol for angina pectoris listing studies meeting standards of 21 CFR 130.12 . 536-540 527-529 October 7 , 1971 , meeting of advisory group on drug - related ...
... angina pectoris - Memorandum by Dr. Crout , re approval of propranolol for angina pectoris listing studies meeting standards of 21 CFR 130.12 . 536-540 527-529 October 7 , 1971 , meeting of advisory group on drug - related ...
Page xix
... angina pectoris _-- April 19 , 1974 , FDA memorandum regarding Depo - Provera , clarification of recall status_ 277-278 447-448 338-339 112-114 450-452 Article from the January 1974 issue of Family Planning Digest entitled " FDA OK's ...
... angina pectoris _-- April 19 , 1974 , FDA memorandum regarding Depo - Provera , clarification of recall status_ 277-278 447-448 338-339 112-114 450-452 Article from the January 1974 issue of Family Planning Digest entitled " FDA OK's ...
Page xix
... angina pectoris . Memorandum by Dr. Crout , re approval of propranolol for angina pectoris listing studies meeting standards of 21 CFR 130.12 . October 7 , 1971 , meeting of advisory group on drug - related carcinogenesis_523–521 sis ...
... angina pectoris . Memorandum by Dr. Crout , re approval of propranolol for angina pectoris listing studies meeting standards of 21 CFR 130.12 . October 7 , 1971 , meeting of advisory group on drug - related carcinogenesis_523–521 sis ...
Page 62
... angina pectoris . A considerable body of published literature exists and numerous presentations have been made at scientific meetings relative to this additional indication . The manufacturer has also performed studies under its ...
... angina pectoris . A considerable body of published literature exists and numerous presentations have been made at scientific meetings relative to this additional indication . The manufacturer has also performed studies under its ...
Common terms and phrases
adequate advice Advisory Committee Act advisory committee meetings agency angina pectoris approval April 13 Apter basis Belton beta blockers BROWN of Ohio Bureau of Drugs carcinogenicity Cardiovascular Chairman clinical trials closed session Commissioner committee members congestive heart failure CONGRES CONGRESS THE LIBRARY consultants contraceptive controlled cromolyn sodium CROUT decision Depo Depo-Provera diethylstilbestrol Director discussion document dosage dose Drug Administration drug application efficacy estrogens evaluation experts FDA staff FDA's Federal Advisory Committee Federal Register files Food and Drug GOLDBERG GOLDHAMMER HUTT Inderal indication investigator issue judgment labeling LIBRARY OF CONGRESS marketed medical officers Medicine medroxyprogesterone acetate ment minutes mittee package insert Panel on Review patients physician placebo present problem propranolol Provera question recommendations record regulatory Renal Advisory Committee response safety SCHMIDT scientific specific statement studies subcommittee submitted substantial evidence summary tion treatment verbatim transcript well-controlled
Popular passages
Page 53 - 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 475 - 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 479 - 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 474 - 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 170 - 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 70 - 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 53 - 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 236 - 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 236 - ... when the application was approved, the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of...