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HRD-80-55 1 (1980-06-06)

handle is hein.gao/gaobabasq0001 and id is 1 raw text is:                                                                                , 11719&



 REP0[-T BY THE


 Comptroller General


orK F E UNITED STATES


      A n s..T        . ... ...... .. .


                AnI uTQesTions On Selected

 FDA Bureau Of Biologics'

 Regulation Activities

 The Food and Drug Administration's Bureau
 of Biologics regulates certain drugs, including
 those used to diagnose and treat allergies and
 to vaccinate people against a number of com-
 municable diseases. This report answers ques-
 tions by several Senators concerning

     --allergenic product regulation;

     --biological tests to ensure product safety,
     purity, and potency;

     --tests to detect metal contaminants;

     --adequacy of product labeling;

     --real or apparent conflict-of interest situ-
     ations; and

     --the relationship between the Bureau's
     intramural research activities and its
     regulatory responsibilities.

 GAO makes several recommendations to HEW
 and also recommends that the Congress amend
 the Public Health Service Act and the Federal
 Food, Drug, and Cosmetic Act to specifically                         112714
 require that drugs regulated by the Bureau
 meet effectiveness standards,





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                                                                       H R D-80-55
   1C'y r)1'                                                         JUNE 6,1980

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