Mon.Dec 16, 2024

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FDA’s Third Party Review Program is Ready for the Next Pandemic, not the LDT Final Rule

FDA Law Blog

By Adrienne R. Lenz, Principal Medical Device Regulation Expert FDA recently released 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review which finalizes the draft guidance of the same title issued in December 2023. We previously discussed the Third Party Review Program in a blog post last year when FDA mentioned its expansion as part of its plan to address the resource gap for review of laboratory developed tests (LDTs) under the LDT final rule.

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Medical Music Mondays: Sorry About the Wait (Urgent Care)

PEMBlog

Urgent Cares are awesome places to receive effective efficient care. they can also be busy. Maybe a female power-pop-punk-alternative band can help celebrate the achievements of our Urgent Care clinicians. Lyrics We just told you that its just a virus Even though diagnosis did not inspire us It doesnt mean that your childs not ill Or the diagnosis needed no skill Its okay that we just reassure And tell you simply what you have in store Youre doing a great job with oral hydration And saline aided

Medical 52
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A new program will look for bird flu in the milk supply

NPR Health

The U.S. Department of Agriculture kicks off a new program looking for highly pathogenic bird flu in the milk supply. Starting this week, they're testing samples of milk intended for pasteurization.

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