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Remote Patient Testing Faces a Cloudy Future under VALID

FDA Law

One example is a short provision that could have a large adverse effect on telehealth-based laboratory testing by sharply restricting grandfathering. Telehealth has become increasing important to the health care system. Telehealth can address significant issues with access and convenience. This is not a trivial matter.

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As the Calendar Turns, Cybersecurity Remains Key Focus of Digital Health Enforcement

FDA Law

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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Senator Durbin Has Questions About FDA’s “Operational Capacity” to Oversee DTC Prescription Drug Advertising Amid Workforce Reductions – Don’t We All?

FDA Law

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. Maximizing patient clinical outcomes and quality of life may ultimately minimize healthcare resource utilization.