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HHS Reverses Course on LDTs: COVID-19 LDTs Again Require FDA Premarket Review

On November 15, 2021, the U.S. Department of Health and Human Services (“HHS”) and the Food and Drug Administration (“FDA”) issued several policy changes governing the regulation of Laboratory Developed Tests (“LDTs”). These changes resume FDA premarket review of COVID-19 LDTs that HHS halted in August 2020 based on a novel statutory interpretation that FDA lacked legal authority to require premarket review of any LDTs absent notice-and-comment rulemaking. Developers of COVID-19 LDTs that do not yet have FDA Emergency Use Authorization (“EUA”) need to be aware of these changes and consider what actions to take in response.

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Drug Pricing: What Happened in 2019 and What to Watch in 2020

Practices: Health Care, Life Sciences, Drug Pricing & Price Reporting

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Have you heard that drug prices are too high? If not, you have not been listening to President Donald Trump, Secretary of Health and Human Services (“HHS”) Alex Azar, or almost any member of Congress. In the past year, a dizzying array of drug pricing actions and proposals have come out of the White House and Congress, as well as the governor’s offices and legislative halls in most states.

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