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  • Title: FDA reform in Congress: AIDS community absent. Food and Drug Administration.
    Author: James JS.
    Journal: AIDS Treat News; 1995 Apr 07; (no 220):4-5. PubMed ID: 11362320.
    Abstract:
    The Food and Drug Administration (FDA) reform movement is quickly moving through the Republican congressional agenda with little AIDS community participation. Some expected proposals are 1) accelerated approval by the FDA, 2) FDA notification with no approval being required before Phase I and II testing could proceed, and 3) limited distribution of information about unapproved uses of approved drugs. Other proposals may also affect the FDA, including speeding the advisory-committee process, and allowing easier export of experimental drugs when legal in the receiving countries.
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