Use of Advisory Committees by the Food and Drug Administration: Hearings ... Ninety-third Congress Second Session [-Ninety-fourth Congress, First Session] ...U.S. Government Printing Office, 1974 |
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Page 20
... for specific drugs . Advisory committees have also been asked to review the data on certain investigational new drugs or marketed drugs and to advise on whether safety and / or efficacy has been established . Today 20.
... for specific drugs . Advisory committees have also been asked to review the data on certain investigational new drugs or marketed drugs and to advise on whether safety and / or efficacy has been established . Today 20.
Page 22
... marketed drugs and ( 3 ) marketed drugs the efficacy of which was in question . NEW DRUGS Pemoline is a drug intended for the treatment of minimal brain dysfunction ( MBD ) in children . The nature of the disorder is poorly understood ...
... marketed drugs and ( 3 ) marketed drugs the efficacy of which was in question . NEW DRUGS Pemoline is a drug intended for the treatment of minimal brain dysfunction ( MBD ) in children . The nature of the disorder is poorly understood ...
Page 24
... MARKETED DRUGS Lithium carbonate is a drug which has been marketed for several years to treat acute symptoms of the manic phase of manic - depressive psychosis . At the time of marketing approval for this indication , there was also ...
... MARKETED DRUGS Lithium carbonate is a drug which has been marketed for several years to treat acute symptoms of the manic phase of manic - depressive psychosis . At the time of marketing approval for this indication , there was also ...
Page 25
... marketed . A summary of problems that were encountered by the Advisory Committee and a panel of experts in reviewing this drug and the action that was taken by the Committee as well as a package insert is submitted for the record ...
... marketed . A summary of problems that were encountered by the Advisory Committee and a panel of experts in reviewing this drug and the action that was taken by the Committee as well as a package insert is submitted for the record ...
Page 26
... marketed for use as anorexigenic agents ( i.e. , appetite suppressing ) for the treatment of obesity . They have been marketed both as single agents and in combination with sedatives . As a result of the NAS / NRC review for efficacy of ...
... marketed for use as anorexigenic agents ( i.e. , appetite suppressing ) for the treatment of obesity . They have been marketed both as single agents and in combination with sedatives . As a result of the NAS / NRC review for efficacy of ...
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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 Commissioner committee members congestive heart failure consultants contraceptive controlled CROUT decision Depo Depo-Provera Devices diethylstilbestrol Director discussion doctors document dosage dose Drug Administration drug application Drug Products estrogens evaluation experts FDA staff FDA's Federal Advisory Committee Federal Register files Food and Drug FOUNTAIN going GOLDBERG GOLDHAMMER HUTT Inderal indication investigator issue judgment labeling marketed matter medical officers Medicine medroxyprogesterone acetate ment minutes mittee opinion package insert Panel on Review patients physician placebo postcoital contraceptive present problem propranolol protocol Provera question recommendations record regulatory Renal Advisory Committee response SCHMIDT scientific specific statement studies subcommittee submitted substantial evidence summary tion treatment verbatim transcript well-controlled
Popular passages
Page 555 - ... (6) personnel and medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy; (7) investigatory files compiled for law enforcement purposes except to the extent available by law to a party other than an agency...
Page 79 - 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 555 - ... (5) inter-agency or intra-agency memorandums or letters which would not be available by law to a party other than an agency in litigation with the agency; (6) personnel and medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy...
Page 79 - ... substantial evidence" means evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate 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, or suggested in the labeling or proposed labeling...
Page 549 - advisory committee" means any committee, board, commission, council, conference, panel, task force, or other similar group, or any subcommittee or other subgroup thereof...
Page 474 - 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 6 - 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 96 - 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 79 - 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 290 - Secretary finds ( 1 ) that the applicant has failed to establish a system for maintaining required records, or has repeatedly or deliberately failed to maintain such records or to make required reports, in accordance with...