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Monthly Round-Up of What to Read on Pharma Law and Policy

Bill of Health

Biomarker qualification at the European Medicines Agency: a review of biomarker qualification procedures from 2008 to 2020. Experts’ Views on FDA Regulatory Standards for Drug and High-Risk Medical Devices: Implications for Patient Care. 2022 Feb 19. Emergency Use Authorizations of COVID-19-Related Medical Products.

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News from the Consumer Technology Association and Withings Further Demonstrates Private Sector’s Role in the Pandemic and Public Health

Health Populi

In a press release on the program, CTA President and CEO Gary Shapiro noted that, “The response to COVID-19 in the U.S. The group includes leading experts who are on the frontlines of dealing with COVID-19, and we hope to create a blueprint that will guide the effective use of technology to combat these scenarios in the future.”.

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The Wait is Over. Or Is It? DEA’s Proposed Rules Around Telemedicine Prescribing: Initial Impressions and Key Takeaways

Health Law Advisor

Background on the Ryan Haight Act The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Ryan Haight Act”) made certain amendments to the CSA which established controls on the remote prescribing of controlled substances. 18 U.S.C. § This deadline came and went, also without meaningful action taken by DEA.

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States and Feds Signal Big Changes to Telehealth Prescribing

Health Law Advisor

In the era of abortion regulation and the wind-down of the COVID-19 public health emergency (“PHE”), new legislation in states such as Utah may be a sign of what is to come for online and telehealth prescribing. The bill currently awaits Governor Spencer Cox’s signature and would take effect sixty (60) days after its signing. [1]

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Physician venture investor talks telehealth, digital therapeutics, Medicaid tech

Healthcare IT News - Telehealth

What has been one digital health investment trend during the COVID-19 pandemic, and why is it important? Before COVID-19, a few companies, such as Livongo, made a splash in the digital health community by going public – Livongo in July 2019. Worse yet, COVID-19 has exacerbated mental and behavioral health issues.

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