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 ...U.S. Government Printing Office, 1976 |
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Стр. 2
... recognized as safe and effective and that they may not be shipped in interstate commerce . It is apparent , however , that FDA is not acting expeditiously to halt their unauthorized in- terstate sale . Instead , FDA has decided to refer ...
... recognized as safe and effective and that they may not be shipped in interstate commerce . It is apparent , however , that FDA is not acting expeditiously to halt their unauthorized in- terstate sale . Instead , FDA has decided to refer ...
Стр. 27
... recognized as safe and effective for its in- tended uses , we would consider the preparation subject to new drug clearance procedures . " Serious question has been raised by the dental community in recent years concerning the safety of ...
... recognized as safe and effective for its in- tended uses , we would consider the preparation subject to new drug clearance procedures . " Serious question has been raised by the dental community in recent years concerning the safety of ...
Стр. 38
... recognized that N2 is a new drug . In 1974 you had attempted to call information to the attention of the Food and Drug Administration , pointing out some of the dangers and hazards of this new drug . Forget about the professional argu ...
... recognized that N2 is a new drug . In 1974 you had attempted to call information to the attention of the Food and Drug Administration , pointing out some of the dangers and hazards of this new drug . Forget about the professional argu ...
Стр. 44
... recognize them as safe and effective when used in accordance with directions . 3. Your opinion ( and the basis for it ) as to whether your colleagues who qualify as experts share your view . This opinion may be based on your contacts ...
... recognize them as safe and effective when used in accordance with directions . 3. Your opinion ( and the basis for it ) as to whether your colleagues who qualify as experts share your view . This opinion may be based on your contacts ...
Стр. 47
... recognized as safe and effective . Are any of you aware of any competent scientific evidence which , if made available to the Dental Products Advisory Committee , might result in a holding by the committee that the N2 type drugs are ...
... recognized as safe and effective . Are any of you aware of any competent scientific evidence which , if made available to the Dental Products Advisory Committee , might result in a holding by the committee that the N2 type drugs are ...
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adequate advertising agency All-Bran American Dental Association American Endodontic Society appropriate cancer CFSAN Chairman cholesterol claims on food clinical Commissioner concerning CONGRESS THE LIBRARY consensus consumers Cosmetic Act criteria Dental Association dentistry develop diet and health dietary fiber dietary supplements discuss disease document draft Drug Administration endodontists evaluate FDA's Federal Food Federal Register fiber Food and Drug food labeling food products FOUNTAIN Glick gutta percha health claims health-related claims health-related information information on food ingredients intake issue Kellogg Kellogg Company letter to dentist LIBRARY OF CONGRESS manufacturers material memo memorandum messages on food misbranded misleading nutrients nutrition nutrition labeling prevention proposed rule public health messages RC2B recommended referred regulations relationship between diet requirements root canal root canal therapy Sargenti Method saturated fat scientific evidence statement subcommittee substantial technique therapeutic tion total dietary pattern treatment vitamins WEISS WERTS YOUNG
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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.