Drug Safety: Hearings Before a Subcommittee of the Committee on Government Operations, House of Representatives, Eighty-eighth Congress, Second Session - [Eighty-ninth Congress, Second Session], 1-2. daļasU.S. Government Printing Office, 1964 - 2377 lappuses |
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Citi izdevumi - Skatīt visu
Bieži izmantoti vārdi un frāzes
abnormalities action adverse reaction animal data animal studies animal tests antidepressant approved basis believe Bendroflumethiazide Bureau of Medicine Chairman chlorcyclizine Ciba clinical investigation clinical studies Commissioner cyclizine decision desmosterol discussed diuretic Division dosage dose Drug Administration drug application DWYER Dyazide edema evaluation experience Food and Drug FOUNTAIN GOLDBERG GRAY hoc committee hospitals human hydrochlorothiazide hypertension IND's indicated Investigational Drug Branch investigational new drug KELSEY Kline & French labeling LARRICK LATTA lesions matter meclizine meclizine and cyclizine Medical Director medical officer meeting memorandum Merck Naturetin opinion Palmisano Parnate patients percent pharmacologist physicians PISANI potassium chloride pregnancy prescription present question RANKIN rats received recommendation reconvening record request responsibility SADUSK safety small bowel sponsor Squibb staff statement subcommittee submitted summary tablets teratogenic teratogenic effect tests thalidomide therapy thiazide tion toxicity tranylcypromine triamterene ulceration warning letter WEINSTEIN
Populāri fragmenti
1269. 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,...
1443. lappuse - ... products conform to appropriate standards of identity, strength, quality, and purity. Laboratory controls shall include...
1022. lappuse - 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...
1436. lappuse - 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...
1482. lappuse - ... 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...
1113. lappuse - Register, to be in the public interest in connection with the performance of duties imposed on that agency by law.
1478. lappuse - 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...
1477. lappuse - 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.
1436. lappuse - ... 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...
1654. lappuse - ... 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...