HHS Drug Import Proposal Is Unlikely To Succeed

By Lisa Dwyer, John Shakow, Seth Lundy, Peter Leininger and Kyle Sampson (January 16, 2020, 5:40 PM EST) -- In late December 2019, the U.S. Food and Drug Administration, an agency operating within the U.S. Department of Health and Human Services, issued two documents — a proposed rule and a draft guidance — intended to establish two pathways for drug importation. The U.S. Department of Health and Human Services previewed these approaches in its Safe Importation Action Plan last July....

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