Volume 3

Interagency coordination in drug research and regulation : hearings before the Subcommittee on Reorganization and International Organizations of the Committee on Government Operations, United States Senate, Eighty-eighth Congress, first session. Agency coordination study, pursuant to S. Res. 27, 88th Cong. Review of cooperation on drug policies among Food and Drug Administration, National Institutes of Health, Veterans' Administration, and other agencies. Mar. 20-June 26, 1963.

  • United States. Congress. Senate. Committee on Government Operations.
Date:
1963
Catalogue details

Licence: Public Domain Mark

Credit: Interagency coordination in drug research and regulation : hearings before the Subcommittee on Reorganization and International Organizations of the Committee on Government Operations, United States Senate, Eighty-eighth Congress, first session. Agency coordination study, pursuant to S. Res. 27, 88th Cong. Review of cooperation on drug policies among Food and Drug Administration, National Institutes of Health, Veterans' Administration, and other agencies. Mar. 20-June 26, 1963. Source: Wellcome Collection.

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    CONTENTS—Part 3 HEARING OF MAY 20, 1963 EXHIBITS 122 Biographical summary on John O. Nestor, M.D____---------- Article in Washington Sunday Star on alleged fraud committed by achifacehinvestigatormioilr: sfled. Lomeco. os elapse. A 1962 reference in a medical magazine to use of Mylicon in Ge Da tas ee a oak Se ts Sg een Se cae i ey 1963 advertisement on Mylicon in Medical World News_____-- 125 Article by Robert P. Fischelis, Ph. D., in American Druggist on medical evaluatiow of new: drivgsi_ i241 Si5 5 gab ose Leu e. Background materials with regard to withdrawal of Entoquel fromytive apaniset cui SPOT ol eiaoaae AM fo nia eee. MER/29—A chronological compilation of brochures, documents, letters, articles, and other records on the history of the drug__ MER/29—Chronology of correspondence between Daniel Stein- berg, M.D. of the National Heart Institute, the Wm. S. Mer- rel Co., officers of the Food and Drug Administration and Ot hewpcsivh # arerise ys. baenss_ stowed Picieiy sat eiqeaasa MER/29—Chronology provided by T. J. Kirby, M.D., Section of Ophthalmology, Mayo Clinic, on early clinical experience_- Comment in the trade press with respect to decision by Health, Education, and Welfare Department Hearing Examiner for suspension of New Drug Application on Altafur__......____- Excerpts of report by Hearing Examiner of Department of Health, Education, and Welfare finding that Altafur was both unsafe and imei cetiveh. ser Jo nodh” i) te sulsge goal.) Official chronology by the Food and Drug Administration with regard to actions on Food Additive Petition for menadione (vihamings)-oi}. 47 wiles. odiniing vad wile Jide Lente Additional excerpts of comments by official and nonofficial sources with respect to Food and Drug Administration action om menadione (vitamin Ks)ii 2. Geol lle eiseen. aseloel. Subsequent letter from the Stuart Co. with respect to Mylicon__ Subsequent letter on behalf of Purdue-Frederick Co. on the drug Parem VOM 2 boca kee oo eee on See ee eee Articles in the trade press with respect to issue of evaluating pediatieidgiiese woswcresde so. tal siewe sd. Losi udomiead Excerpts from various sources on the issue of alleged “‘rigging”’ of research in some New Drug Applications.___..___._..____~- Subsequent memorandum by Senator Hubert H. Humphrey, listing excerpts of 8 years of comments by various authorities on Food and Drug Administration’s need for consultation__ -- Comments by National Academy of Sciences on professional consultation for the Food and Drug Administration. ______-- Excerpts of comments on and by Food and Drug Administration as to what constitautes.a. “new drug’ 2... 2 enllen ee - 28 Page 780 1030 777 792 800 801 813 814 816 922 940 945 948 955 958 968 970 972 975 978 982 987