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116350 1 (1981-09-16)

handle is hein.gao/gaobadyuu0001 and id is 1 raw text is: 








          UNITED STATES GENERAL ACCOUNTING OFFICE
                   WASHINGTON, D.C. 20548




                                     FOR RELEASE ON DELIVERY
                                     Expected at 10:00 A.M. EDT
                                     September 16, 1981



                          STATEMENT OF
EDWARD A. DENSMORE, DEPUTY DIRECTOR, HUMAN RESOURCES DIVISION
                           BEFORE THE
  SUBCOMMITTEE ON NATURAL RESOURCES, AGRICULTURE RESEARCH
AND ENVIRONMENT, HOUSE COMMITTEE ON SCIENCE AND TECHNOLOGY



                            ON THE                           Ill1111111111111
              FOOD AND DRUG ADMINISTRATION'S                     116350
        EFFORTS TO SPEED UP THE DRUG REVIEW PROCESS


     Mr. Chairman, and members of the Subcommittee, we are pleased

to be here today to summarize and discuss our review of the

Food and Drug Administration's (FDA's) efforts to speed up its

drug review process. Our prior report of May 28, 1980, to the

Subcommittee on Science, Research and Technology indicated that

FDA's drug review process was lengthy and that it took almost

as long to approve important drugs as drugs of less importance.

Our report identified the following factors which we believed

affected FDA's efforts to approve drugs in a timely manner:

     --FDA guidelines regarding documentation to be submitted
        with a new drug application (NDA) and the formatting
        of such documentation were imprecise and subject to
        varying interpretations.


6'{~ 3I)~)

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