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.
Sound Physicians
NOVEMBER 5, 2024
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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CDOCS
JANUARY 12, 2021
They’re hosting a webinar on Thursday, January 14th to discuss this integration and how it can work in your dental practice.</p> <p>CEREC design tools are widely used in many dental practices.</p> It saves dentists time and money while attracting patients and adding valuable services.</p>
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
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.
FDA Law Blog
JUNE 21, 2023
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this CDRH’s effort aligns with the FDA-wide effort to utilize digital health technologies that are discussed in recent draft guidance documents as follows: Draft Guidance on Decentralized Clinical Trials for Drugs, Biological Products, and Devices. By Philip Won & McKenzie E. We previously blogged on the draft guidance here.
Physician's Practice
JUNE 20, 2025
Those who pave new roads and create new paths find the connections between what others have done and what works in their practices. Dr. Christian Chaussy, a urologist in Munich, Germany, noted pitting on the surface of an aircraft as it approached the sound barrier—a unique occurrence caused by the shock wave created in front of a drop of moisture.
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