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Interim Final Rule Implements Controversial Surprise Billing Arbitration Provisions

On Thursday, October 7, the Biden Administration published in the Federal Register its second interim final rule implementing the “No Surprises Act,” which became law on December 27, 2020 as part of the FY 2021 Consolidated Appropriations Act.

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COVID-19 Disruptions of International Clinical Trials: Comparing Guidances Issued by FDA, EMA, MHRA and PMDA

Practices: Health Care

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The COVID-19 pandemic has had a major impact on the conduct of clinical trials worldwide. Recognizing this impact, national authorities have issued guidance for sponsors, investigators and institutional review boards (IRBs)/research ethics committees (RECs) regarding the conduct of clinical trials. The chart below summarizes guidance from the U.S. Food and Drug Administration (“FDA”) (updated March 27, 2020), the European Medicines Agency (“EMA”) (dated March 27, 2020), the United Kingdom Medicines and Healthcare Products Regulatory Agency (“MHRA”) (updated March 24, 2020), and Japan’s Pharmaceuticals and Medical Devices Agency (“PMDA”) (dated March 27, 2020).

View the PDF to read the guidance.

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