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Telemedicine and the Prescribing of Controlled Substances After the End of The Covid-19 Pandemic Emergency: DEA Announces Two Significant Proposed Rules: Read the Summary Below, But Learn All the Details and More at HPM’s Webinar on March 23, 2023 (Details Forthcoming….)

FDA Law Blog

That emergency declaration is set to expire on May 11, 2023. While no “special registration” will yet be required to engage in telemedicine prescribing of controlled substances, DEA is proposing parameters to guide the practice of telemedicine encounters in a post-COVID world. 21 U.S.C. § 802(54)(D)(i). 21 U.S.C. § 802(54)(D)(i).

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Clinical Trials Join the Remote Work Revolution: FDA’s New Draft Guidance on Decentralized Clinical Trials

FDA Law Blog

Section 3606(a) of the Food and Drug Omnibus Reform Act (FDORA) directed FDA to “issue or revise draft guidance that includes recommendations to clarify and advance the use of decentralized clinical studies to support the development of drugs and devices,” not later than December 29, 2023. DHTs include monitoring instruments (e.g.,

Clinic 59
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Anti-Asian Hate: Russell Jeung, Lingsheng Li, & Jessica Eng

GeriPal

We discuss: What is considered a hate incident, how is it tracked, what do we know about changes over time The wider impact of Anti-Asian hate on older Asians, who are afraid to go out, leading to anxiety, social isolation, loneliness, decreased exercise, missed appointments and medications. Jessica, welcome back to GeriPal. So here is a little bit.

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Telemedicine in a Post-Pandemic World: Joe Rotella, Brooke Calton, Carly Zapata

GeriPal

This DEA is taking 6-months to consider how to move forward vis a vis restrictions and requirements for telehealth in a post-pandemic world. See the AAHPM Legislative Action Center [link] Write to the DEA, with guidance from AAHPM’s comments to the DEA March 2023. Now is the time to act, dear listeners! Joe: I do. But not Space Oddity.