FDA Law Blog
SEPTEMBER 22, 2024
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.
FDA Law Blog
JUNE 24, 2024
HPM) Director Dara Katcher Levy will present an informative webinar on the newly released AMCP Format for Formulary Submissions version 5.0. In this educational session, Dara Katcher Levy, alongside Jonathan Toft, PharmD, MBA, Principal at Formulary and Rebate Optimization, MedImpact Healthcare Systems, Inc.,
FDA Law Blog
MAY 26, 2025
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. By Andrew J. The EO and DOJ memo were followed by a May 1, 2025 announcement of a report from the U.S. See 21 U.S.C.
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