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 83
... going to do in the future . Simultaneously , the OTC panels are peaking right now . We have 10 or 12 of them meeting right at the moment , and that is going to go on for 1 or 2 years and then will decline . So that from the standpoint ...
... going to do in the future . Simultaneously , the OTC panels are peaking right now . We have 10 or 12 of them meeting right at the moment , and that is going to go on for 1 or 2 years and then will decline . So that from the standpoint ...
Page 84
... going to have a regulatory agency , it should be staffed with all of the qualified professionals you need and can get . That doesn't mean you shouldn't get the benefit of outside expertise through advisory committees . I want to get ...
... going to have a regulatory agency , it should be staffed with all of the qualified professionals you need and can get . That doesn't mean you shouldn't get the benefit of outside expertise through advisory committees . I want to get ...
Page 86
... going to get an estimation of anticipated costs , but we do want it to be within bounds so that we don't have a situation such as I have described . Mr. FOUNTAIN . I had planned to get into those figures , so I think this is a good time ...
... going to get an estimation of anticipated costs , but we do want it to be within bounds so that we don't have a situation such as I have described . Mr. FOUNTAIN . I had planned to get into those figures , so I think this is a good time ...
Page 97
... going on right now is the review of the GRAS lists , these minifood additive agreements , in which the Federation of American Societies of Experimental Biology and their committees are serving the function of gathering and reviewing and ...
... going on right now is the review of the GRAS lists , these minifood additive agreements , in which the Federation of American Societies of Experimental Biology and their committees are serving the function of gathering and reviewing and ...
Page 104
... going to try to see that the applications , which they were to look at , were to be integrated with the reviews in - house so that we could get the job done within our 180 - day time limit . And there was a fair amount of discussion on ...
... going to try to see that the applications , which they were to look at , were to be integrated with the reviews in - house so that we could get the job done within our 180 - day time limit . And there was a fair amount of discussion on ...
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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...