FDA reform in Congress: AIDS community absent. Food and Drug Administration. Clearinghouse, P.O. Box 6003, Rockville, MD 20849-6003. 800-458-5231 ext. 5023. NLM AIDSLINE Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.

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FDA reform in Congress: AIDS community absent. Food and Drug Administration. Clearinghouse, P.O. Box 6003, Rockville, MD 20849-6003. 800-458-5231 ext. 5023.

AIDS Treat News. 1995 Apr 7;(no 220):4-5. Unique Identifier : AIDSLINE AIDS/95700343
James JS

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.
Keywords: Acquired Immunodeficiency Syndrome/*DRUG THERAPY Clinical Trials, Phase I Clinical Trials, Phase II Drug Approval Drug Labeling Human United States United States Food and Drug Administration NEWSLETTER ARTICLE

KWDacquiredimmunodeficiencysyndrome/KWDdrugtherapyclinicaltrials,phaseiclinicaltrials,phaseiidrugapprovaldruglabelinghumanunitedstatesunitedstatesfoodanddrugadministrationnewsletterarticle
951130
M95B0912

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