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World Stem Cell Summit panel cautions over stepped up HCT/P enforcement, reimbursement issues

Speaking at the World Stem Cell Summit hosted by the Regenerative Medicine Foundation last week, Hogan Lovells partners Mike Druckman, Stuart Langbein, and Thomas Beimers discussed evolving ...

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PREVENT Pandemics Act to build pandemic capabilities and implications for medical product developers

Earlier this week, the U.S. Senate HELP Committee released a discussion draft of the “Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act”...

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Meta ban on health-targeting ads will soon restrict clinical trial recruiters

A new ban on “Detailed Targeting” options for advertisers on Facebook and other Meta-owned social media platforms – which includes restricting...

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FDA RWD/RWE regulatory considerations in draft guidance highlight opportunities and challenges

This month, FDA released the latest in a series of agency guidance to advance the development and use of real-world data (RWD) and real-world evidence (RWE) in clinical trial designs for...

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DEA proposes revised rules for identifying and reporting suspicious orders of controlled substances

Today, the U.S. Drug Enforcement Administration (DEA) released its long-awaited proposed rule on Suspicious Orders Monitoring System (SOMS) obligations under the federal Controlled...

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DEA issues interim final rule implementing 2018 Farm Bill

In the prepublication version of today’s Federal Register, the U.S. Drug Enforcement Agency (DEA) issued an interim final rule (IFR) implementing conforming changes to DEA’s...

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