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This document was published by the U.S. Department of Health and Human Services on March 19, 2019. The purpose of the guidance is to provide sponsors non-clinical and clinical recommendations specific to the development of systemic drug products, with a focus on long-acting systemic drug products, regulated within the Center for Drug Evaluation and Research at the Food and Drug Administration for the prevention of sexually acquired human immunodeficiency virus-1 (HIV-1) infection . . .
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