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Green Practice News: April 2025

My Green Doctor

New Research: Teaching Patients about Climate Resilience Newly published original research co-authored by My Green Doctor’s Dr. Todd Sack concludes that, “ the medical office waiting room appears to be an accepted, time-efficient, and effective site to communicate knowledge on climate change and health. ” Contact us today! of total U.S.

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How Many Hours are Really in a Day?

FDA Law Blog

We noted that the draft guidance’s discussion on determining a device’s contact duration raised concern as it contradicted ISO 10993-1:2018, Biological evaluation of medical devices —Part 1: Evaluation and testing within a risk management process. the new draft guidance and ISO 10993-1: 2018) leads to more uncertainty for sponsors.

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New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

FDA Law Blog

Chemical characterization identifies and quantifies chemicals that may be released from the medical device, while a toxicological risk analysis (TRA) evaluates the risks to the patient associated with the chemicals identified. of ISO 10993-1:2018, but is extremely burdensome and not referenced in the related ISO 10993-18.

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

FDA Law Blog

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released 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review which finalizes the draft guidance of the same title issued in December 2023. The Agency has reportedly been trying to improve the program, as we discussed in 2018 and 2020.

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Every Day Counts for PTE: Court Finds FDA’s Reinterpretation of Testing Phase Arbitrary and Capricious

FDA Law Blog

As with other FDA-regulated products, such as human drugs and medical devices, the “regulatory review period” is composed of a “testing phase” and a “review phase.” In February 2010, an oral formulation of BRAVECTO, a medication to treat and prevent fleas and tick infestation in dogs, was the subject of an INAD submitted to the Agency.

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Diabetes in Late Life: Nadine Carter, Tamryn Gray, Alex Lee

GeriPal

When I’m on palliative care consults and attending in our hospice unit we have to counsel patients about deprescribing and de-intensifying diabetes medications. Our last podcast was with Laura Petrillo in 2018 – 5 years ago seems ancient history – though many of the points still apply today (e.g. Goldilocks zone).

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Medical Cannabis Revisted: A Podcast with David Casarett and Eloise Theisen

GeriPal

David is a physician who wrote the book “ Stoned: A Doctor’s Case for Medical Marijuana ” and gave a TED talk on “ A Doctor’s Case for Medical Marijuana ” that was watched over 3 million times. laughter] Alex 01:39 Material here for songs related to medical marijuana or marijuana in general. Eric 01:34 Yeah.

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