2019 IT Manufacturing Specialization 
The Medical Futurist
JUNE 17, 2025
Researchers in 2019 developed a machine learning method to accurately quantify immune cells in the vicinity of oral cancer cells. We’ve all been through this as a kid and childhood memories stick with us, just recalling this might send a shiver down your spine. For patients, it promises more accurate care and better outcomes.
FDA Law
MAY 8, 2023
See 21 CFR 807.81(a)(3) a)(3) and 21 CFR 814.39(a) a) , and related guidance documents (e.g., here for a 510(k) device and here for a PMA device). The draft guidance follows the December 2022 enactment of the Food and Drug Omnibus Reform Act of 2022 (FDORA).
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FDA Law
JUNE 28, 2021
On June 26, 2021, during the Minnesota legislature’s special session, the Minnesota House of Representatives passed HF33, an omnibus health and human services bill. Whether HF33 is enacted or not, state legislative initiatives aimed at combatting the opioid epidemic continue to be a moving target for opioid manufacturers.
FDA Law
OCTOBER 2, 2024
We find it surprising that a PCCP may not be submitted with a Special 510(k), given a Special 510(k) may be used to modify an existing device where well-established methods are available to evaluate the change. FDA, Guidance for Industry, The Special 510(k) Program (2019). Change Guidance at 8. Draft Guidance at 34.
Physician's Weekly
JUNE 19, 2025
Bob’s journey here begins in 2019 — the first day of high school for his daughter, Mary. In January of last year, Cole went to a Walgreens in Appleton, Wisconsin, to get refills on the medication he used to control his asthma. He’d been taking it for years, and he expected to pay about seventy bucks. He left without it.
GeriPal
MAY 8, 2025
Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution. It’s there.
FDA Law
JUNE 10, 2025
DEA publishes the Special Surveillance List to inform about potential illicit uses of a laboratory supply and reminds that civil penalties may be imposed on businesses that distribute a laboratory supply with reckless disregard for the illegal uses to which it will be put. DEA published the original Special Surveillance in May 1999.
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