Answers To Questions On Selected Fda Bureau Of Biologics' Regulation Activities V. HRD-80-55

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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