FDA Law Blog

MAY 4, 2023

Cato — On May 2nd, FDA released a new draft guidance with recommendations for decentralized clinical trials (DCTs) for drugs, biologics, and devices. In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories.

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FDA Law Blog

FEBRUARY 27, 2023

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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GeriPal

AUGUST 15, 2024

Really, across the board, there was a spike, and it seemed to have, seems to have come down from 2022 to 2023. We do a lot of clinical focused discussions. We shouldn’t be screening every older age and adult who comes into our clinic about these incidents for different reasons. As far as the numbers, pretty significantly.

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GeriPal

JULY 20, 2023

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. Brooke: So I think of telehealth as the umbrella. Eric: Yeah.

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