FDA Law Blog

MAY 4, 2023

This draft guidance builds on recommendations that FDA initially developed early in 2020, in response to the COVID-19 challenges (see our blog post on these recommendations here ). Study visits can be conducted using telehealth visits if in-person interaction is not necessary. Trial personnel can also be sent to participant’s homes.

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FDA Law Blog

MARCH 27, 2023

As promised during the 90-minute program, we provide our slides here, and a recording of the program, here (passcode.

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FDA Law Blog

NOVEMBER 15, 2022

He also will advise clients on matters related to compliance with the Controlled Substances Act and DEA regulations, and matters involving drug compounding, telehealth, and telemedicine. “I Claud will represent regulated entities on litigation, enforcement, and compliance matters, internal investigations, and data privacy concerns.

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FDA Law Blog

FEBRUARY 27, 2023

The rule would permit a practitioner using a telemedicine encounter to prescribe controlled substances without an in-person visit under various situations involving both an audio-visual telehealth evaluation, or an in-person evaluation performed by a “referring” provider.

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FDA Law Blog

JUNE 21, 2023

telemedicine and telehealth solutions (e.g., We previously blogged on the draft guidance here. At-home medical technologies include, but are not limited to, monitoring and wearable devices (e.g., measure and track vital signs such as continuous glucose monitor, ECG monitor, blood pressure monitor, fall detector, actigraphy, etc.),

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FDA Law Blog

JANUARY 5, 2023

Claud — As we turn into the New Year, we offer a few items of interest in digital and telehealth regulation, enforcement, and compliance that may provide some helpful guideposts for stakeholders. By John W.M.

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ABIM

JUNE 4, 2025

Visit the ABIM Blog for reports of prior meetings. The group discussed evolving trends in telehealth and how to capture that as a category of community practice. They also noted a distinction in telehealth practices between remote consultations in different states and using telehealth to treat patients who live nearby.

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ABIM

JUNE 11, 2025

Visit the ABIM Blog for reports of prior meetings. Shnekendorf noted that physician distribution is a top concern for IDSA, which aims to address it partially through its compensation initiative and telehealth data. Learn More Subscribe to the ABIM Blog to stay on top of the latest news.

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FDA Law Blog

JANUARY 23, 2023

FDA declared 2016 the “Year of Clinical Trials Diversity” and that year, issued two guidance documents, one for drug and one for device studies, to standardize collection and reporting of race and ethnicity data in submissions for clinical trials (see our blog post on the final device-related guidance here ).

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FDA Law Blog

JUNE 1, 2025

The Protecting Patients from Deceptive Drug Ads Online Act, co-sponsored with Senator Mike Braun (R-IN), seeks to close regulatory gaps by empowering FDA to issue Warning Letters and impose fines on social media influencers and telehealth companies that promote prescription drugs without proper disclosures of risks and side effects.

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