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HPM Director Dara Katcher Levy to Present Webinar on AMCP Format for Formulary Submissions v5.0

FDA Law Blog

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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Dedicated ICU management: Navigating the transition

Sound Physicians

When we meet with hospitals who utilize a local pulmonology group about a critical care partnership, we aim to involve the local pulmonary practice early and deliberately when appropriate. Sound partnerships are forged with patient needs at the forefront, and this means involving those who have cared for patients in the ICU up to that point.

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Integration of CEREC inLab and 3D Printing: Maximizing Same-Day Opportunities

CDOCS

They&rsquo;re hosting a webinar on Thursday, January 14th to discuss this integration and how it can work in your dental practice.</p> Joseph Faber and Jeffrey Kay are partners in an emerging DSO that currently has 7 locations and have fully integrated CEREC same-day technology in all of their practices.

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Let’s Listen to Patients: FDA Releases Final Guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Studies

FDA Law Blog

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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A Final LDT Rule in April!? Will FDA be prepared?

FDA Law Blog

During the October 31, 2023 webinar discussing the proposed rule, stakeholders sought clarity from FDA officials on the Agency’s plan to address the resource gap. 14] Thus, while the Third-Party Review Program is not well‑utilized generally, it is not utilized at all by the in vitro diagnostic industry. 31, 2023), [link]. [10]

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CDRH Seeks Public Comment on How to Increase Patient Access to At-Home Use Medical Technologies

FDA Law Blog

We also note this CDRH’s effort aligns with the FDA-wide effort to utilize digital health technologies that are discussed in recent draft guidance documents as follows: Draft Guidance on Decentralized Clinical Trials for Drugs, Biological Products, and Devices. We previously blogged on the draft guidance here.

Medical 45
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Lead, follow or get out of the way

Physician's Practice

Use whatever methods are available (articles, Webinars, videos, social media, podcasts, etc.) Form or be part of a focus group where you can ask questions and share concerns that will impact your judgment. Make an informed decision. Listen and learn. to help understand the pros and cons of an issue. Take the leap at your own pace!