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FDA Hosts Webinar for Stage 1 Requirements under LDT Final Rule

FDA Law Blog

The webinar largely consisted of summarizing the general requirements under Parts 803, 806 and 820.198, which we do not reproduce here ( but see another of our prior blog posts discussing these requirements and their applicable to LDTs in greater detail; you can also find FDA’s slides from the webinar here ). By Steven J.

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Navigating Executive Orders and DOJ Memos That Threaten Criminal Prosecution

FDA Law Blog

Hull & JP Ellison At our webinar earlier this month, we talked about Administration priorities as they relate to the FDC Act and noted that we expect much to remain the same with respect to enforcement. Specifically, these are procedures and drugs used in providing what HHS had, until recently, referred to as gender-affirming care.