The Code of Federal Regulations of the United States of AmericaU.S. Government Printing Office, 1994 The Code of Federal Regulations is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. |
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105. lappuse - The responsibility for the human subject must always rest with a medically qualified person and never rest on the subject of the research, even though the subject has given his or her consent.
274. lappuse - If offered for use In arthritis or rheumatism, in juxtaposition therewith, the statement: Caution — If pain persists for more than 10 days, or redness Is present, or In conditions affecting children under 12 years of age, consult a physician immediately.
162. lappuse - 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,...
149. lappuse - Secretary finds (1) that the applicant has failed to establish a system for maintaining required records, or has repeatedly or deliberately failed to maintain such records or to make required reports, in accordance with a regulation or order under...
149. lappuse - ... and preserve its identity, strength, quality, and purity and were not made adequate within a reasonable time after receipt of written notice from the...
198. lappuse - ... name by which such drug is titled in the part or panel of the label thereof which is presented or displayed under customary conditions of purchase. (d) A drug shall not be considered to be misbranded by reason of failure of its label to bear the statement "Warning — May be habit forming...
105. lappuse - Because it is essential that the results of laboratory experiments be applied to human beings to further scientific knowledge and to help suffering humanity, the World Medical Association has prepared the following recommendations as a guide to every physician in biomedical research involving human subjects.
271. lappuse - Warning — In case of deep or puncture wounds or serious burns consult physician. If redness, irritation, swelling or pain persists or increases or if infection occurs consult physician.
105. lappuse - The right of the research subject to safeguard his or her integrity must always be respected. Every precaution should be taken to respect the privacy of the subject and to minimize the impact of the study on the subject's physical and mental integrity and on the personality of the subject. 7. Physicians should abstain from engaging in research projects involving human subjects unless they are satisfied that the hazards involved are believed to be predictable.
8. lappuse - The newness of a drug may arise by reason (among other reasons) of: (1) The newness for drug use of any substance which composes such drug, in whole or in part, whether it be an active substance or a menstruum, excipient, carrier, coating, or other component. (2) The newness for a drug use of a combination of two or more substances, none of which is a new drug.