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Green Practice News: April 2025

My Green Doctor

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. ” According to the 2023 report of the Lancet Countdown, mortality caused by extreme heat events increased by 53.7% The healthcare sector contributes 8.5%

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A Long Time Coming: DEA Regs Finally Authorize Schedule II Prescription Partial Fills

FDA Law

Now, in July 2023, DEA has finally issued its final rule amending its regulations for partial filling of prescriptions for schedule II substances. 46,983 (July 21, 2023). 21 U.S.C. § Partial Filling of Prescriptions for Schedule II Controlled Substances, 85 Fed. 78,282 (Dec. The Final Rule a.

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You don’t need labs to medically clear a psych patient

PEMBlog

When should the emergency physician obtain lab tests to medically clear such patients? Also, while evidence for lab evaluation based on history and exam findings was established for adults, children were considered to have a medical etiology (organic psychosis) until proven otherwise. Acute onset psychosis is relatively rare.

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CDRH Seeks Public Comment on How to Increase Patient Access to At-Home Use Medical Technologies

FDA Law

Cato — On June 1, CDRH announced that it is seeking public comment on questions regarding how CDRH can facilitate access to medical technologies designed for use outside of traditional clinical settings, particularly in the home. At-home medical technologies include, but are not limited to, monitoring and wearable devices (e.g.,

Medical 45
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The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

FDA Law

When FDA published the fiscal years (FY) 2023-2027 goals letter at the end of August, making known their commitments and planned initiatives for the coming years, we were both excited by many of the announcements, while recognizing the real success will come from how the Agency implements them.

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Senators to DEA: Consider Treaty Obligations In Marijuana Rescheduling

FDA Law

We blogged in February about the October 2023 letter from former DEA Administrators, Ms. Democratic senators also weighed in, supporting rescheduling to schedule III in December 2023. Whether DEA is consulting the Department of State about treaty obligations regarding marijuana and diplomatic implications of rescheduling?

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Warning Letters: An Untapped Source for Understanding When Device Changes Require a New 510(k)

FDA Law

Such assessments are highly individualized and difficult to map onto the few examples provided by FDA in its guidance. For example, in an October 13, 2023 WL to ReNovo, Inc., Manufacturers should, therefore, welcome any additional source of examples of device changes to aid in evaluating their own.