A Legislative History of the Federal Food, Drug, and Cosmetic Act and Its Amendments, Volume 22U.S. Department of Health, Education, and Welfare, Public Health Service, Food and Drug Administration, 1979 - Cosmetics |
From inside the book
Results 1-5 of 100
Page 100
... approved by the Secretary available to practitioners on written request . Nothing in this paragraph shall be construed to exempt any person from any labeling requirements imposed by or under other pro- visions of this Act . " ( b ) The ...
... approved by the Secretary available to practitioners on written request . Nothing in this paragraph shall be construed to exempt any person from any labeling requirements imposed by or under other pro- visions of this Act . " ( b ) The ...
Page 127
... approved by the FDA setting forth informa tion on a drug's uses , side effects , dosages , etc. ) . 12. Extending the certification procedure to all antibiotics and providing standards for the consideration of their exemption . In ...
... approved by the FDA setting forth informa tion on a drug's uses , side effects , dosages , etc. ) . 12. Extending the certification procedure to all antibiotics and providing standards for the consideration of their exemption . In ...
Page 129
... approved by the Secre- tary of Health , Education , and Welfare on the drug's efficacy and side effects . 3. To give the medical officers of the FDA adequate time to appraise the possible side effects and efficacy of a new drug , no new ...
... approved by the Secre- tary of Health , Education , and Welfare on the drug's efficacy and side effects . 3. To give the medical officers of the FDA adequate time to appraise the possible side effects and efficacy of a new drug , no new ...
Page 135
... approved were very vigorous . The fact that thalidomide was not approved for sale in the United States was due in part to the insight and courage of FDA's medical officer and in part to the coincidence that just about the time that the ...
... approved were very vigorous . The fact that thalidomide was not approved for sale in the United States was due in part to the insight and courage of FDA's medical officer and in part to the coincidence that just about the time that the ...
Page 152
... approved as a tranquilizer could be promoted as an antiarthritic drug , sedative , antihistamine , etc. , without the new claims being approved by the FDA . He asserts that the FDA's only remedy in such cases is to seize the drug as ...
... approved as a tranquilizer could be promoted as an antiarthritic drug , sedative , antihistamine , etc. , without the new claims being approved by the FDA . He asserts that the FDA's only remedy in such cases is to seize the drug as ...
Other editions - View all
Common terms and phrases
adequate amended by adding American animal testing antibiotics Antitrust approved ask unanimous consent August August 23 authority bacitracin bill CARROLL certification chairman clause clinical Commissioner compulsory licensing Congress CONGRESSIONAL RECORD controls Cosmetic Act Cosmetic Act 21 cost doctors Drug Administration drug application DRUG INDUSTRY ACT druggist EASTLAND efficacy enactment end thereof establishment exemption experience Federal Food filed Food and Drug Government hearings House HUMPHREY ingredient inserting inspection investigation issued JAVITS Judiciary Committee KEFAUVER labeling legislation license Madam President majority manufacture ment metic minority mittee official name patent percent person physicians prednisone prescribed prescription drugs PRESIDING OFFICER printed problem proposed provisions pursuant recommended regulations Republican request respect safe safety section 505 Senator from Tennessee Senator yield staff staffing Subcommittee subsection testing thalidomide thereof the following tion United United States Code Welfare words
Popular passages
Page 67 - CHANGES IN EXISTING LAW In compliance with subsection (4) of rule XXIX of the Standing Rules of the Senate, changes in existing law made by the bill, as reported, are shown as follows (existing law proposed to be omitted is enclosed in black brackets, new matter is printed in italic, existing law in which no change is proposed is shown in roman...
Page 692 - The judgment and decree of the court affirming, modifying, or setting aside, in whole or in part, any such order of the Commission shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification as provided in sections 239 and 240 of the Judicial Code, as amended (USC, title 28, sees. 346 and 347).
Page 687 - ... effective periods for certificates, and other conditions under which they shall cease to be effective as to certified batches and as to portions thereof...
Page 401 - ... the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice...
Page 671 - food additive" means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food...
Page 71 - ... (A) the investigations, reports of which are required to be submitted to the 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 thereof; (B) the results of such tests show that such drug is unsafe for use under such conditions...
Page 68 - ... if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food; or (4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health...
Page 693 - A separate notice shall be given for each such inspection, but a notice shall not be required for each entry made during the period covered by the inspection. Each such inspection shall be commenced and completed with reasonable promptness.
Page 215 - 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 79 - Department. (b) For purposes of enforcement of this Act, officers or employees duly designated by the Secretary, upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge...