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FDA Wants Your Input on Cybersecurity for Servicing of Medical Devices

FDA Law

By Philip Won — On June 17, 2021, FDA has released a discussion paper to discuss cybersecurity issues related to the servicing of medical devices. FDA is now expanding its cybersecurity effort in servicing of medical devices. What are the cybersecurity challenges and opportunities associated with the servicing of medical devices?

Medical 52
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FDA Redux? CDRH Policy and EUA Templates for Monkeypox Tests Following Public Health Emergency Declaration Mirror FDA’s COVID-19 Approach

FDA Law

This led to delays in releasing a uniform policy and templates for COVID-19, as well as many other problems (see blog post chronicling some of the challenges here ). academic medical center laboratories). academic medical center laboratories). On the same day, September 7, CDRH published a policy for monkeypox tests.

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FDA Safety Communications: A Potential Provider Pitfall

FDA Law

25, 2022), [link] , considered whether a provider’s use of a medical device that is the subject of an FDA safety communication constitutes per se evidence of wanton disregard, which would warrant punitive damages. Wasserstein — The New Jersey Supreme Court, in its August 25, 2022 opinion in Mirian Rivera v. Valley Hospital, Inc.

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Direct-to-consumer advertising distorts prescription drugs’ benefits and costs

Common Sense Family Doctor

It also does not change the context that most patients overestimate drug safety and that the most heavily advertised drugs have lower added benefit compared with similar medications.

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The MAHA Assessment’s Implications: Drugs (Part One)

FDA Law

The Assessment highlights various trends related to chronic disease diagnoses (such as increasing rates of autism spectrum disorder and attention deficit hyperactivity disorder) with associated trends in prescribing practices. That leaves us to speculate what the implications of this Assessment will be.