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Expert Analysis

What Pharma Cos. Must Know About FDA Off-Label Guidance

By Jacqueline Berman and Maarika Kimbrell (October 27, 2023, 5:26 PM EDT) -- The U.S. Food and Drug Administration issued a much-awaited draft guidance on Oct. 24 revising its approach to the dissemination of scientific information on unapproved uses of approved or cleared medical products....

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