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. 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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CDOCS

JANUARY 12, 2021

They&rsquo;re hosting a webinar on Thursday, January 14th to discuss this integration and how it can work in your dental practice.</p> By leveraging existing technologies such as CEREC inLab, 3D printing enables better responsiveness to patient needs, significantly reduces manufacturing times, and opens up new treatment options.

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FDA Law Blog

DECEMBER 11, 2023

Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ). We take this date with a grain of salt given the frequency with which these dates are missed and given the volume of comments filed. (It

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FDA Law Blog

FEBRUARY 28, 2022

The Guidance provides practical advice for device manufacturers to utilize patient engagement in clinical studies. Finally, mark your calendars for the upcoming March 22, 2022 FDA webinar about this Guidance. The FDA webinar information can be found here.

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FDA Law Blog

SEPTEMBER 20, 2021

First, CDER will publish a new MAPP (the Manual for Policies and Procedures, meant to guide CDER staff in their review activities and interactions with sponsors) describing: (1) early engagement with sponsors and (2) “science- and risk-based approaches” for CMC development that “may be warranted and utilized.

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