Use of Advisory Committees by the Food and Drug Administration: Hearings Before a Subcommittee of the Committee on Government Operations, House of Representatives, Ninety-third Congress, Second Session ...

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U.S. Government Printing Office, 1976
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Стр. 4 - Mr. Chairman, and members of the subcommittee, I wish to thank you for the opportunity to appear before you today in support of planning funds for the Eau Galle River flood control project.
Стр. 21 - Secretary's approval, the regulation is then forwarded to the Office of Information and Regulatory Affairs in the Office of Management and Budget (OMB) for review under Executive Order 12291.
Стр. 302 - drug," as used in this Act, shall include all medicines and preparations recognized in the United States Pharmacopoeia or National Formulary for internal or external use, and any substance or mixture of substances intended to be used for the cure, mitigation, or prevention of disease of either man or other animals. The term
Стр. 305 - Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions.
Стр. 304 - ... no person shall introduce or deliver for introduc-tion into interstate commerce any...
Стр. 298 - Formulary, or any supplement to any of them ; and (2) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (3) articles (other than food) intended to affect the structure or any function of the body of man or other animals...
Стр. 298 - drug" means (1) articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them ; and (2) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and...
Стр. 298 - ... articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any articles specified in clause (A), (B), or (C); but does not include devices or their components, parts, or accessories.
Стр. 304 - new drug" means — (1) Any drug the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety of drugs, as safe for use under the conditions prescribed, recommended, or suggested in the labeling thereof, except that such a drug not so recognized shall not be deemed to be a "new drug...
Стр. 407 - Commissioner Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 Dear Dr.

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