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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Results 1-5 of 94
Page 23
... considered the expert panel's report at its May 1973 meeting and voted to adopt the recommendations of the report . The Committee recommended to the FDA that additional clinical studies should be obtained and that these should be six ...
... considered the expert panel's report at its May 1973 meeting and voted to adopt the recommendations of the report . The Committee recommended to the FDA that additional clinical studies should be obtained and that these should be six ...
Page 24
... , nevertheless , a clinical reality . It was therefore considered desirable to review the available evidence supporting the new use and to either update the labeling to include this use with appropriate directions for the physician , or 24.
... , nevertheless , a clinical reality . It was therefore considered desirable to review the available evidence supporting the new use and to either update the labeling to include this use with appropriate directions for the physician , or 24.
Page 27
... have been invaluable in providing a credible and effective mechanism for giving the Agency well considered advice on these difficult problems . Advisory 34-574 74 - 3 CONCLUSION Mr. Chairman , we have demonstrated , in my 27.
... have been invaluable in providing a credible and effective mechanism for giving the Agency well considered advice on these difficult problems . Advisory 34-574 74 - 3 CONCLUSION Mr. Chairman , we have demonstrated , in my 27.
Page 47
... considered the time required by FDA personnel in preparation for Advisory Committee meetings and the time available to Committee members for their review of data . In connection with this latter consideration , in 1971 , each FDA ...
... considered the time required by FDA personnel in preparation for Advisory Committee meetings and the time available to Committee members for their review of data . In connection with this latter consideration , in 1971 , each FDA ...
Page 48
... considered advisable to utilize our standing Advisory Committees and provide them with an increased role in drug evaluation rather than to appoint entirely separate committecs . These Committees have , on occasion , reviewed data ; have ...
... considered advisable to utilize our standing Advisory Committees and provide them with an increased role in drug evaluation rather than to appoint entirely separate committecs . These Committees have , on occasion , reviewed data ; have ...
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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...