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HRD-81-125 1 (1981-07-17)

handle is hein.gao/gaobabcez0001 and id is 1 raw text is: UNITED STATES GENERAL ACCOUNTING OFFICE WASHINGTON, D.C. 20548 HUMAN RESOURCES DIVISION JUL 17 1981 B- 20 2161 The Honorable Henry A. Waxman Chairman, Subcommittee on Health and the Environment Committee on Energy and Commerce House of Representatives 115882 Dear Mr. Chairman: Subject: /Federal Drug Development Program§? HRD-81-125) This is in response to your request that we develop informa- tion on the Federal Government's involvement in drug development programs to assist the Subcommittee in its consideration of the Federal role in developing orphan drugs. We have had several briefings with your office to discuss information we had obtained during our review. As agreed with your office, this report contains the results of our work as presented during our briefings. The report is divided into two sections: --Introduction and scope - includes a discussion of Federal controls over development and marketing of drugs. --A description of Federal drug development programs - includes 12 programs identified by our study, highlight- ing the basis for Government involvement, the scope of their activities, the status of drug development in these programs, and some factors to consider in establishing new drug development programs. As agreed with your office, we did not obtain written agency comments on this report. However, officials who were responsible for each subject discussed in this report did review a draft per- taining to their respective activities. Their comments have been considered in preparing the final report. (103964) . .... .. ........,,.. !l, :: .... il ...........

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