Drug Safety: Hearings Before a Subcommittee of the Committee on Government Operations, House of Representatives, Eighty-eighth Congress, Second Session...
U.S. Government Printing Office, 1964 - Drugs - 2377 pages
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action additional animal appear application approval associated August basis believe bottles Branch BRESSLER Bureau of Medicine Chairman changes clinical combination Commissioner committee concerning considered correct course deaths decision depression Director discussed Division Drug Administration effect evaluation evidence experience fact firm Food and Drug FOUNTAIN further give given GOLDBERG GRAY hearing hospital human important indicated inspection inspector June KELSEY labeling Laboratories LARRICK letter manufacturing matter medical officer meeting memorandum months occurred officer opinion Parnate patients percent period person physicians possible potassium practice prepared present problem proposed question RANKIN reactions reason recall received recommendation record referred representatives request responsible SADUSK sent Smith staff statement studies submitted suggested taken tests tion treatment warning weeks
Page 1269 - 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 1022 - Secretary when the application was approved, shows that such drug is not shown to be safe for use under the conditions of use upon the basis of which the application was approved...
Page 1436 - A drug or device shall be deemed to be adulterated — (a) (1) If it consists in whole or in part of any filthy, putrid, or decomposed substance; or (2) if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health...
Page 1482 - ... the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice...
Page 1113 - Register, to be in the public interest in connection with the performance of duties imposed on that agency by law.
Page 1478 - Balancing relative hardships, Congress has preferred to place it upon those who have at least the opportunity of informing themselves of the existence of conditions...
Page 1477 - The prosecution to which Dotterweich was subjected is based on a now familiar type of legislation whereby penalties serve as effective means of regulation. Such legislation dispenses with the conventional requirement for criminal conduct — awareness of some wrongdoing. In the interest of the larger good it puts the burden of acting at hazard upon a person otherwise innocent but standing in responsible relation to a public danger.
Page 1436 - ... the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug are inadequate to preserve its identity, strength, quality, and purity...
Page 1654 - ... applicable to the article on which such notice was based, such guaranty or undertaking, or a verified copy thereof, shall be made a part of such presentation of views. (b) Upon request, seasonably made, by the person to whom a notice appointing a time and place for the presentation of views under section 305 of the act has been given, or by his representative, such time or place, or both such time and place, may be changed if the request states reasonable grounds therefor. Such request shall...