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HRD-82-16 1 (1981-11-23)

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REPORT BY THE



Comptroller General


OF THE UNITED STATES


Speeding Up The Drug Review

Process: Results Encouraging--

But Progress Slow



Th' Food and Drug Administration's efforts
to speed drug review are encouraging. Since
Oc tober I, 1978, FDA has approved more
dr gs in less time than before despite an in-
creased workload. The greatest reductions
were made in approvals of important drugs
(d ugs that in F DA's judgment provide a
th rapeutic gain over any marketed drugs).
H cwever these approvals represent only
about 4( percent of those in process since
00ober I, 1978, and it is too early to tell
wlether the positive trend will continue.
Reduction of approval time has not been
cosistent throughout all FDA divisions, and
processing times should be further reduced.
G40 is recommending actions that the Secre-
tary of Health and Human Services could take
to further reduce drug review time.


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       H RD-82-16
NOVEMBEA 23. 1981


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