Interagency Coordination in Drug Research and Regulations: Hearings ...1962 - 3228 pages |
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action adverse drug reactions adverse reactions advertising Advisory agency agents amendment American Medical Association animals BURNEY carisoprodol cerebral palsy Chairman chloroquine claims clinical investigators clinical trials committee deanol diazepam Director disease doctors dosage dose Drug Administration Drug Application drug companies drug industry drug reactions drug research Drug Safety drug testing editor Education efficacy Efocaine ethical evaluation exhibit experience experimental FDA's Federal firms Food and Drug Government hospital human Institute interest KLUMPP labeling Laboratories Larrick letter medical journals medical profession medical schools medicine ment meprobamate Merrell Parnate patients percent pharmaceutical industry Pharmaceutical Manufacturers Association pharmacology Philadelphia physician placebo effect preparations President problem professional promotion question received regulations reports response scientific scientists Senator GRUENING side effects statement subcommittee submitted sustained-action tetracyclines thalidomide therapeutic therapy tion toxicity tranylcypromine treatment triparanol University Valium
Popular passages
Page 2969 - ASSOCIATION (AMA) seeks to promote the science and art of medicine and the betterment of public health.
Page 2936 - ... in all advertisements and other descriptive printed matter issued or caused to be issued by the manufacturer, packer or distributor with respect to that...
Page 2446 - The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.
Page 2444 - ... obtain the consent of such human beings or their representatives, except where they deem it not feasible or, in their professional judgment, contrary to the best interests of such human beings.
Page 2460 - The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature. 3 The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.
Page 2446 - The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problems under study that the anticipated results will justify the performance of the experiment. 4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
Page 2337 - 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 2441 - I yield back the remainder of my time. The PRESIDING OFFICER. The question Is on agreeing to the amendment of the Senator from California.
Page 2446 - ... 10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.
Page 2570 - ... because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use...