FDA Law Blog

SEPTEMBER 23, 2021

is pleased to announce that Jeffrey Shapiro and Serra Schlanger will present at this year’s Food and Drug Law Institute virtual Advertising and Promotion for Medical Products Conference on October 13–15. Hyman, Phelps & McNamara, P.C. We can offer our readers a discount of 15% off registration using code AP15.

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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This draft guidance builds on recommendations that FDA initially developed early in 2020, in response to the COVID-19 challenges (see our blog post on these recommendations here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

FEBRUARY 27, 2023

The Ryan Haight Act was enacted to address the legal “grey area” in which prescribers and pharmacies operated via the creation of two new statutory requirements: 1) the at least one “in-person” medical evaluation requirement for prescribing practitioners, 21 U.S.C. § 829(e); and 2) the modified registration requirement for online pharmacies.

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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. Combination products are sharing the digital moment with those classified solely as medical devices. By John W.M.

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ABIM

JUNE 4, 2025

Visit the ABIM Blog for reports of prior meetings. See the discussion on the Special Consideration IMG (International Medical Graduates) Pilot Pathway below.) The group discussed evolving trends in telehealth and how to capture that as a category of community practice. The following is a summary of the spring meeting.

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ABIM

JUNE 11, 2025

Visit the ABIM Blog for reports of prior meetings. This is now being reviewed by the American Board of Medical Specialties, which oversees ABIM. After similar explorations in gastroenterology , hematology and medical oncology , ABIM announced the development of several new focused LKAs planned for launch in those areas in 2026.

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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

Senator Durbins letter references a January 2023 study from the Journal of the American Medical Association, which found that more than two-thirds of drugs advertised on television were considered to have low therapeutic value.

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