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HRD-82-37 1 (1982-03-08)

handle is hein.gao/gaobabcyv0001 and id is 1 raw text is: 




BY THE U.S. GENERAL ACCOUNTING OFFICE


Report To The Secretary Of

Health And Human Services


FDA Can Further Improve Its Adverse

Drug Reaction Reporting System



The Food and Drug Administration has im-
proved the use of its adverse drug reaction re-
porting system since GAO reported on it in
1974. Medical officers are more familiar with
the system and are using it more. However,
improvements can still be made.

Many adverse reaction reports do not get to
the Division maintaining the system and many
others require a long time to get into the sys-
tem. Some of the missing or late reports in-
volved serious reactions which were not dis-
cussed in the drug labeling. Reporting by non-
manufacturer sources, such as hospitals or
physicians, could also be increased.

GAO recommends actions to resolve these
and other problems.


    HRD-82-37
MARCH 8, 1982


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    117703

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