FDA Law
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
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. This update incorporates new guidelines and enhancements to address the evolving needs of the healthcare industry, improving the clarity and utility of the submitted information.
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FDA Law
FEBRUARY 28, 2022
This Guidance embodies the Agency’s belief that: “Successful adoption of legally marketed medical devices increasingly depends on patient acceptance of that technology and patients being more engaged in the healthcare process, along with demonstrated public health benefits.”. The FDA webinar information can be found here.
FDA Law
OCTOBER 10, 2023
We find that this information is noteworthy for manufacturers to consider. FDA encourages manufacturers to submit a pre-submission to discuss the animal study protocol with the Agency before submitting a 510(k) application. programming, monitoring, maintenance). separate patient labeling). separate patient labeling).
FDA Law
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 memo also instructs U.S. And the memo welcomes qui tam whistleblower suits with knowledge of such violations.
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