Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight
FDA Law Blog: Biosimilars
JULY 7, 2024
By Gail H. Javitt — In its final rule on laboratory developed tests (LDTs) (see our prior blog here ), FDA acknowledged that “some laboratories may lack familiarity, experience, or existing infrastructure for complying with FDA requirements” and made multiple references to a “small entity compliance guidance” that the agency intended to publish to “provide additional guidance to small businesses.
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