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By Mahnu V. Davar, Philip R. Desjardins, Abeba Habtemariam, and Phillip V. DeFedele, Arnold & Porter | The FDA made a small change with big consequences when it amended its definition of in vitro diagnostics. Here’s what it means for lab-developed tests. |
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By Amanda Mack and Alicja Fiedorowicz, Dark Horse Consulting Group | This article provides a summary and analysis of the FDA's new draft guidance, Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products. The public comment period ends July 29. |
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