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.
Sound Physicians
MARCH 12, 2025
With the absence of intensivists on the ground in these community hospitals, the question becomes how to treat these patients where and when they need care. Partnering with a telemedicine critical care team alleviates the pressure on both the hospitalist team and the patients. All rights reserved. Receive blog updates directly to your inbox.
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FDA Law Blog
JUNE 21, 2023
For those who are interested in learning more about the decentralized clinical trial draft guidance, please check out the FDA’s webinar on June 20, 2023. By Philip Won & McKenzie E. As noted by CDRH, there are “innovation deserts” when it comes to conditions that primarily affect diverse populations.
Physician's Practice
JUNE 20, 2025
For example, practices have adopted electronic medical records (EMR) systems only to find that productivity in the practice ground to a halt. Successful practices have found ways to work around the loss of productivity and ultimately made Electronic Medical Records (EMRs) work effectively in their practices. So, you need to decide.
FDA Law Blog
NOVEMBER 22, 2022
When necessary to help prevent or mitigate a foodborne illness outbreak or assist in implementing a recall, firms must generally provide an electronic sortable spreadsheet containing information that FDA requests on specified CTEs, FTL foods, date ranges, and TLCs. 7, 2022 at 1 p.m.
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