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Page 8120 - For which there exists substantial clinical experience (as used in this section this means substantial clinical experience adequately documented in medical literature or by other data (to be supplied to the...
Page 8120 - 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 7972 - ... on the basis of which it can fairly and responsibly be concluded by such experts that the drug is safe and effective for such uses...
Page 8047 - Stat. 704, 705, amended the act of 1910 to readThat whenever an invention described in and covered by a patent of the United States shall hereafter be used or manufactured by or for the United States...
Page 8071 - Funds appropriated pursuant to this Act shall not be expended by the United States Government for the acquisition of any drug product or pharmaceutical product manufactured outside the United States if the manufacture of such drug product or pharmaceutical product in the United States would involve the use of, or be covered by, an unexpired patent of the United States which has not previously been held invalid by an unappealed or unappealable judgment or decree of a court of competent jurisdiction,...
Page 7991 - Please let us know if we can be of further assistance. Sincerely yours, M. .1. RYAN, Director, Office of Legislative Services. Senator NELSOX. Is there any sound reason for the Department of Defense having its inspectors and the Veterans' Administration making plant inspections?
Page 7984 - ... cetera. We have developed certain inhouse biological availability requirements for abbreviated new drug applications but information and techniques thus far in this whole area have been slow in coming and must be considered preliminary. On the basis of currently available evidence, the quality of marketed drugs in regard to their purity and the uniformity of content of active ingredients is not suspect. This includes all marketed drugs, generic as well as brand name. Even though there have been...
Page 8092 - Force recommends that the Department of Health, Education, and Welfare should establish or support a publication providing objective, up-to-date information and guidelines on drug therapy, based on the expert advice of the medical community.
Page 7968 - Edwards. Well, I think there is probably no simple answer to solving that problem. Certainly, one of the answers is to better communicate to the medical profession the fact that in today's drug scene the brand names and the generic name drugs that are approved by the Food and Drug Administration are for all practical purposes equal drugs in terms of their potency, uniformity, et cetera. I think frankly, we have not done enough in communicating this kind of information to the practicing profession....
Page 7975 - Labeling and other promotional claims have been evaluated as "effective," "probably effective," "possibly effective," "ineffective," "ineffective as a fixed combination," and "effective but," and a report for each drug in the study has been submitted to the Commissioner. (2) The Food and Drug Administration is processing the reports, seeking voluntary action on the part of the drug manufacturers and distributors in the elimination or modification of unsupported promotional claims, and initiating...