Rachel Park

Morrison & Foerster LLP

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Latest Posts › Coronavirus/COVID-19

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FDA Will Once Again Accept Pre-Submissions For All In Vitro Diagnostic Tests

The U.S. Food and Drug Administration (FDA) released a statement on May 31, 2022, that its Center for Devices and Radiological Health (CDRH) will once again be accepting all pre-submissions for all in vitro diagnostic (IVD)...more

6/6/2022 / CDRH , Coronavirus/COVID-19 , Diagnostic Tests , Federal Register , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Public Health

FDA Oks Mail-Order Mifepristone: State Laws May Inhibit Its Use

In December 2021, the U.S. Food and Drug Administration announced that it would make permanent its COVID-19-era enforcement policy, which allows for the delivery of the abortion pill (MIFEPREX (mifepristone)) by mail and...more

1/27/2022 / Coronavirus/COVID-19 , Drug Distribution , Drug Treatment , Food and Drug Administration (FDA) , REMS , Telehealth , Telemedicine

Key Takeaways From FDLI's Enforcement, Litigation, And Compliance Conference Keynote Address

FDLI hosted a virtual conference December 9–10, 2021. The keynote address was given by Arun Rao, Deputy Assistant Attorney General at the United States Department of Justice (DOJ). Arun Rao discussed the efforts of the...more

12/22/2021 / Clinical Trials , Consumer Protection Laws , Coronavirus/COVID-19 , Department of Justice (DOJ) , Enforcement Actions , False Statements , Food and Drug Administration (FDA) , Fraud , Opioid , Pharmaceutical Industry

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