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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Page 6
... evaluation . In June 1975 , I spoke to the Office of Compliance , and an official there told me that they thought they had a case but needed the concurrence of the scientific evaluation section . In July 1975 , I spoke with Dr. Gilkes ...
... evaluation . In June 1975 , I spoke to the Office of Compliance , and an official there told me that they thought they had a case but needed the concurrence of the scientific evaluation section . In July 1975 , I spoke with Dr. Gilkes ...
Page 7
... evaluating , and summarizing , was a method of distraction - FDA hoping that I would become discour- aged . I am not convinced that my report was read until the situation became active due to Congressman Gude's intercession . The Bureau ...
... evaluating , and summarizing , was a method of distraction - FDA hoping that I would become discour- aged . I am not convinced that my report was read until the situation became active due to Congressman Gude's intercession . The Bureau ...
Page 10
... Evaluation of Media Used in Electric Pulp Testing " , Oral Surgery , Oral Medicine & Oral Pathology , March , 1969 . " Basic Corrective Endodontics " , J. Maryland State Dental Association , April , 1970 . " Rationale of Successful ...
... Evaluation of Media Used in Electric Pulp Testing " , Oral Surgery , Oral Medicine & Oral Pathology , March , 1969 . " Basic Corrective Endodontics " , J. Maryland State Dental Association , April , 1970 . " Rationale of Successful ...
Page 12
... evaluate some of the drug's components and some of the claims . In order to discuss the use of N2 for teeth in need of endodontic therapy , we must first define that which we are to discuss . The symbol N2 , as currently used , can ...
... evaluate some of the drug's components and some of the claims . In order to discuss the use of N2 for teeth in need of endodontic therapy , we must first define that which we are to discuss . The symbol N2 , as currently used , can ...
Page 14
... evaluation , including 5 and 10 year - and even more-- recalls . Those studies were not based upon collective opinions such as asked for in the N2 questionnaire whose criterion of absence of pain does not adequately validate success ...
... evaluation , including 5 and 10 year - and even more-- recalls . Those studies were not based upon collective opinions such as asked for in the N2 questionnaire whose criterion of absence of pain does not adequately validate success ...
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Expressions et termes fréquents
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
Fréquemment cités
Page 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.
Page 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.
Page 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
Page 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.
Page 304 - ... no person shall introduce or deliver for introduc-tion into interstate commerce any...
Page 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...
Page 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...
Page 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.
Page 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...
Page 407 - Commissioner Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 Dear Dr.