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 |
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Page 61
... reason INTAL is withorn in eases where its use has permitted a reduction maintenance dose of sterck . In such cris , content clo upervision of the patient i nannual mee the r * may be suchtega reippisarance of severe manifestations of ...
... reason INTAL is withorn in eases where its use has permitted a reduction maintenance dose of sterck . In such cris , content clo upervision of the patient i nannual mee the r * may be suchtega reippisarance of severe manifestations of ...
Page 64
... reason for this is that sympathetic ture Varies widely between individuais . Since there is no reliable test to estimate syn- pathetic tone or to determine whether total beta blockade has been achieved , proper dosage requires titration ...
... reason for this is that sympathetic ture Varies widely between individuais . Since there is no reliable test to estimate syn- pathetic tone or to determine whether total beta blockade has been achieved , proper dosage requires titration ...
Page 75
... reason INTAL is withorwn in eases where its use has permitted a reffurfion in th mountenance dese of strice . In such cr continued elnas upervision of the patient i , mentul since the re may be sudden rappositance of severe munitist ...
... reason INTAL is withorwn in eases where its use has permitted a reffurfion in th mountenance dese of strice . In such cr continued elnas upervision of the patient i , mentul since the re may be sudden rappositance of severe munitist ...
Page 75
... reason for this is that sympathetic ture Varies widely between individu.is , Since there is no reliable test to estimate syn- pathetic tone or to determine whether total beta blockade has been achieved , proper dosage requites titration ...
... reason for this is that sympathetic ture Varies widely between individu.is , Since there is no reliable test to estimate syn- pathetic tone or to determine whether total beta blockade has been achieved , proper dosage requites titration ...
Page 75
... reason , with the exiption of phoo Chrifti stoma , IN @@ shall be with- € 4 hours prior to st , at which time all chemical and phreatic effects Bre fone da cording to avarta Ilustrer , in care of etic evidence . surgery . siner INE KA ...
... reason , with the exiption of phoo Chrifti stoma , IN @@ shall be with- € 4 hours prior to st , at which time all chemical and phreatic effects Bre fone da cording to avarta Ilustrer , in care of etic evidence . surgery . siner INE KA ...
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...