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. daļas

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U.S. Government Printing Office, 1964 - 2377 lappuses

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Exhibit 13Investigational use circular for Dyazide
893
Supporting documents for subcommittee summary of
924
Exhibit 15Status of review of INDs May 3 1965
940
Exhibit 17Supporting documents for subcommittee summary of
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zine
989
Exhibit 1Subcommittee summary on Meclizine Cyclizine and Chlorcy
1003
Exhibit 2Findings of NIH perinatal research project with respect
1040
Exhibit 3Letter to Hon L H Fountain from George P Larrick trans
1048
June 9 1965 drug surveillance Meclizine Cyclizine and Chlorcy cli
1051
Exhibit 5Memorandum to George P Larrick Commissioner of Food
1056
Exhibit 6Memorandum from Arthur Ruskin M D summarizing views
1066
Exhibit 7Memorandum of telephone conversation between Dr William
1093
Exhibit 8Memorandum to the Secretary of Health Education and Wel
1107
June 10 1965 drug surveillance EsidrixK HydrodiurilKA
1115
Exhibit 2Original warning letter on Naturetin with
1139
Exhibit 3Revised warning letter on Naturetin with
1145
Exhibit 4Memorandum concerning high probability of inadequate
1155
Exhibit 1Supporting documents for subcommittee summary 11
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Statement of
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Exhibit 3Evaluation of Parnate by Arthur Ruskin M D Deputy
1254
Exhibit 6Evaluation of medical literature concerning the effectiveness
1262
Exhibit 7Letter to Dr Jonathan Cole National Institutes of Health from
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Exhibit 9Article from the Medical Journal of Australia dated May
1276
Exhibit 10Article from the American Journal of Psychiatry dated Feb
1294
Exhibit 11Letter from Dr Bernard Brodie Chief Laboratory of Chemical
1305
Exhibit 12Wire from Gerald Klerman M D withdrawing as witness
1316
Exhibit 13Exchange of correspondence between Dr Fritz A Freyhan
1329
Exhibit 14Memorandum of telephone conversation between W Donald
1331
Exhibit 15Memorandum of conference on Parnate with Dr Glueck
1344
Exhibit 16Memorandum from W B Rankin Assistant Commissioner
1351
Exhibit 18Exchange of memoranda between the Medical Director and
1360
Exhibit 19Summaries of side effects and deaths associated with Parnate
1375
Exhibit 20Documents pertaining to discrepancies in the animal data
1408
Exhibit 21Reports on interviews of employees of Hazleton Laboratories
1417
Hearings held on Page
1437
Exhibit 1Regulations pertaining to current good manufacturing prac
1444
Exhibit 2Organizational charts of the Food and Drug Administration
1454
Subcommittee summary concerning FDA handling of labeling
1506
Exhibit 13Memorandum by James Nakada Division of Field Opera
1642
Exhibit 14Excerpt from Federal Food Drug and Cosmetic Act relat
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Exhibit 15Documents pertaining to reinspection at hospital where Page
1670
Exhibit 16Intraagency memorandum concerning label mixups occur
1685
Exhibit 17Memorandum by Dr Arthur Ruskin Deputy Director
1715
Exhibit 21Memorandum of telephone conversations on September 8
1736
Exhibit 23Memorandum of telephone conversations involving Mr Nevis
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Statement of longdistance telephone calls from U S Food
1812
Exhibit 29Excerpts from report of inspection at Abbott Laboratories
1841
Hearings held on Page
1861
Exhibit 1List of INDs for DMSO submitted by sponsors other than Page
1901
Exhibit 4Letter from Acting Chief of FDAs Investigational Drug
1907
Letters statements etc submitted for the record
1909
Exhibit 6Letter from January 22 1966 Lancet concerning teratogenic
1919
MK665 ETHYNERONE
1947
Exhibit 1Current criteria for the evaluation of progestational agents
1953
DRUG ADVERTISING HEARINGS OF MAY 25 AND 26 1966
1966
Statement of George P Larrick Commissioner Food and Drug Adminis
1994
Exhibit 1Objections to proposed drug advertising regulations filed
2004
Exhibit 2Selected ads demonstrating some of the problems of prescrip
2022
Prescription drug advertising casestype of action taken
2036
Exhibit 4FDA press release on seizure of Serax for false advertising
2042
Exhibit 5Ad for Measurin from the March 21 1966 issue of the Journal
2050
Exhibit 6Memorandum of conference between representatives of
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Exhibit 8Working agreement between FTC and FDA
2087
Testimony of
2090
Exhibit 9Summary of drug trade ad expenditures
2102
Exhibit 1Members of the FDA Advisory Committee on the Abuse
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Exhibit 3Correspondence between Chairman Fountain and former Com
2159
Exhibit 4Article from the New Republic May 14 1966 concerning dan
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Exhibit 6Draft of a paper on the therapeutic use of highdose LSD ses
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Exhibit 7Psychedelic Therapy a paper by Charles Savage M D
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Journal for the Study of Interper
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Appendix 1General
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Appendix 2Material relating to part 2 of the hearings
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Appendix 4Material relating to part 4 of the hearings
2354
Belson J Joseph Food and Drug Officer Division of Case Supervision
2369
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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...

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