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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. (FDA Javitt & Jeffrey N.

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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. By John W.M. Combination products might be part drug, part device, or part software or hardware.

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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

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.