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
... issue of Family Planning Digest entitled " FDA OK's Limited Depo - Provera Use " . Chronology of NDA 16-762 for propranolol ( " Inderal " ) for angina pectoris prepared by subcommittee staff .. Correspondence regarding the recall of ...
... issue of Family Planning Digest entitled " FDA OK's Limited Depo - Provera Use " . Chronology of NDA 16-762 for propranolol ( " Inderal " ) for angina pectoris prepared by subcommittee staff .. Correspondence regarding the recall of ...
Page viii
... issue which the advisory body was not qualified to decide . " The committee recommended that HEW and FDA , and I quote , " confine their use of scientific advisory bodies to the consideration of clearly defined issues which are within ...
... issue which the advisory body was not qualified to decide . " The committee recommended that HEW and FDA , and I quote , " confine their use of scientific advisory bodies to the consideration of clearly defined issues which are within ...
Page 2
... issue which the advisory body was not qualified to decide . " The committee recommended that HEW and FDA , and I quote , " confine their use of scientific advisory bodies to the consideration of clearly defined issues which are within ...
... issue which the advisory body was not qualified to decide . " The committee recommended that HEW and FDA , and I quote , " confine their use of scientific advisory bodies to the consideration of clearly defined issues which are within ...
Page 20
... issues with major impact and circumscribed scientific issues . Examples of the former include the 1968 survey and report on intrauterine contraceptive devices prepared by the Obstetrics and Gynecology Advisory Committee ; the ...
... issues with major impact and circumscribed scientific issues . Examples of the former include the 1968 survey and report on intrauterine contraceptive devices prepared by the Obstetrics and Gynecology Advisory Committee ; the ...
Page 21
... issues with major impact and circumscribed scientific issues . Examples of the former include the 1968 survey and report on intrauterine contraceptive devices prepared by the Obstetrics and Gynecology Advisory Committee ; the ...
... issues with major impact and circumscribed scientific issues . Examples of the former include the 1968 survey and report on intrauterine contraceptive devices prepared by the Obstetrics and Gynecology Advisory Committee ; the ...
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...