Food, Drug, and Cosmetic Act Amendments of 1977: Hearings Before the Subcommittee on Health and Scientific Research of the Committee on Human Resources, United States Senate, Ninety-fifth Congress, First Session, on S. 1831 ... and Related Bills, July 26 and 27, 1977U.S. Government Printing Office, 1978 - 767 pages |
From inside the book
Results 1-5 of 100
Page 35
... believe that adequate data to enable him 15 to assess the safety and efficiency of the new drug can be 16 obtained by a voluntary reporting system and that such full 17 marketing and commercial distribution does not present seri- 18 ous ...
... believe that adequate data to enable him 15 to assess the safety and efficiency of the new drug can be 16 obtained by a voluntary reporting system and that such full 17 marketing and commercial distribution does not present seri- 18 ous ...
Page 136
... referred to as the ' Commis- 22 sion ' ) . The Commission shall thereupon investigate the 23 pertinent facts . 24 " INSTITUTION OF PROCEEDING 25 " SEC . 399d . Whenever the Commission has reason to 26 believe- 1 2 3 4 5 6 7 8 9 10 136.
... referred to as the ' Commis- 22 sion ' ) . The Commission shall thereupon investigate the 23 pertinent facts . 24 " INSTITUTION OF PROCEEDING 25 " SEC . 399d . Whenever the Commission has reason to 26 believe- 1 2 3 4 5 6 7 8 9 10 136.
Page 219
... believe that clinical pharmacology is one of those disci- plines that probably needs more support , needs augmentation of good , trained people . So in a general way I am oriented favorably to the concept . Whether it should be set up ...
... believe that clinical pharmacology is one of those disci- plines that probably needs more support , needs augmentation of good , trained people . So in a general way I am oriented favorably to the concept . Whether it should be set up ...
Page 230
... believe that it is premature for us to consider legislatively prescribing FDA's structure at this time . I am , however , deeply and personally interested in and committed to attracting the best scientific talent to the Agency that can ...
... believe that it is premature for us to consider legislatively prescribing FDA's structure at this time . I am , however , deeply and personally interested in and committed to attracting the best scientific talent to the Agency that can ...
Page 232
... believe that 1 authority to require post - marketing studies , to place restrictions on distribution of drugs after marketing , and a good system of post - marketing surveillance are fundamental . These authorities should be seen as ...
... believe that 1 authority to require post - marketing studies , to place restrictions on distribution of drugs after marketing , and a good system of post - marketing surveillance are fundamental . These authorities should be seen as ...
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Common terms and phrases
95TH CONGRESS adverse drug reactions adverse reactions advertising advisory agency amended American application appropriate approval authority believe bill bioavailability brand Center Chairman chemical Clinical Pharmacology clinical pharmacy Commissioner Committee compendium consumer Cosmetic Act cost digitalis digitoxin digoxin distribution diuretic doctor Drug Administration Drug Board drug products Drug Science Board drug therapy established evaluation Federal Food Food and Drug Formulary functions Hospital investigations July 27 labeling legislation medicine ment National Drug Science NDSB patient package inserts penicillin person pharmacists Phase Phase IV physician potassium practicing physician practitioners prednisone prescribing prescription drugs present problem professional proposed record regulations require responsible safety sample San Joaquin SCHWEIKER scientific Secretary Section 502 Senator KENNEDY Senator SCHWEIKER specific standards statement studies Subcommittee testimony testing thereof tion United United States Code
Popular passages
Page 121 - ... 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 thereof; (2) the results of such tests show that such drug is unsafe for use under such conditions...
Page 467 - No. 5. If confirmed, are there any issues from which you may have to recuse or disqualify yourself because of a conflict of interest or the appearance of a conflict of interest?
Page 125 - That no additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal...
Page 657 - The community is concerned with the maintenance of professional standards which will insure not only competency in individual practitioners, but protection against those who would prey upon a public peculiarly susceptible to imposition through alluring promises of physical relief.
Page 118 - Treasury a loan guarantee and interest subsidy fund (hereinafter in this subsection referred to as the ''fund") which shall be available to the Secretary without fiscal year limitation, in such amounts as may be specified from time to time in...
Page 636 - Labeling shall be clear and truthful in all respects and may not be false or misleading in any particular. It shall state the intended uses and results of the product; adequate directions for proper use; and warnings against unsafe use, side effects, and adverse reactions in such terms as to render them likely to be read and understood by the ordinary individual, including individuals of low comprehension, under customary conditions of purchase and use.
Page 25 - Secretary finds (1) that clinical or other experience, tests, or other scientific data show that such drug is unsafe for use under the conditions of use upon the basis of which the application was approved...
Page 25 - 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 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,...
Page 482 - Any drug dispensed by filling or refilling a written or oral prescription of a practitioner licensed by law to administer such drug shall be exempt from the requirements of...
Page 77 - RIBICOFF) introduced the following bill; which was read twice and referred to the Committee on Labor and Public Welfare A BILL To amend the Federal Food, Drug, and Cosmetic Act to prohibit the administration of the drug diethylstilbestrol (DES) to any animal intended for use as food, and for other purposes.