A Legislative History of the Federal Food, Drug, and Cosmetic Act and Its Amendments, Volum 21

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Department of Health, Education and Welfare, Public Health Service, Food and Drug Administration, 1979
 

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Side 20 - If any party shall apply to the court for leave to adduce additional evidence, and shall show to the satisfaction of the court that such additional evidence is material and that there were reasonable grounds for failure to adduce such evidence in the proceeding before the Secretary...
Side 56 - ... 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...
Side 44 - As used in this paragraph (e), the term "established name", with respect to a drug or ingredient thereof, means (A) the applicable official name designated pursuant to section 508, or (B) if there is no such name and such drug, or such ingredient, is an article recognized in an official compendium, then the official title thereof in such compendium, or (C) if neither clause (A) nor clause (B) of this subparagraph...
Side 14 - Secretary, the court may order such additional evidence to be taken before the Secretary and to be adduced upon the hearing in such manner and upon such terms and conditions as to the court may seem proper. The...
Side 50 - ... the establishment and maintenance of such records, and the making of such reports to the Secretary, by the manufacturer or the sponsor of the investigation of such...
Side 20 - A copy of such petition shall be forthwith transmitted by the clerk of the court to the Secretary...
Side 19 - 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...
Side 14 - Secretary thereupon shall file in the court the record of the proceedings on which he based his action, as provided in section 2112 of title 28, United States Code. Upon the filing of such petition, the court shall have jurisdiction to affirm the action of the Secretary or to set it aside, in whole or in part, temporarily or permanently, but until the filing of the record, the Secretary may modify or set aside his order.
Side 60 - The Bureau of the Budget advised there would be no objection to the submission of this report from the standpoint of the administration's program. Sincerely yours, EDWARD GUDEMAN, Under Secretary of Commerce.
Side 46 - 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...

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