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HHS Releases Provider Relief Fund Reporting Requirements

This week, HHS released detailed guidance, as well as a summary, on reporting required for Provider Relief Funding (PRF) recipients and delayed the opening of the reporting system to January 15, 2021. These requirements do not apply to the Nursing Home Infection Control, Rural Health Clinic Testing, or the HRSA Uninsured Program funding streams.

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COVID-19 Disruptions of International Clinical Trials: Comparing Guidances Issued by Key European National Regulatory Authorities, the Australian Department of Health, Brazil’s ANVISA, Health Canada and Singapore’s HSA

Practices: Health Care

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Coronavirus Landing Site

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. Following up on an earlier alert that was released on April 2, 2020, available here summarizing guidance from FDA, EMA, MHRA and PMDA, the below chart summarizes guidance related to COVID-19 and clinical trials released by additional national regulatory authorities. The chart below summarizes guidance from the European Medicines Agency (“EMA”), the French National Agency for Medicines and Health Products Safety (“ANSM”), the German Federal Ministry of Health (“BfArM”), the Italian Medicines Agency (“AIFA”), the Spanish Agency for Medicines and Health Products (“AEMPS”), Switzerland's Swissmedic and swissethics, the Australian Department of Health, the Brazilian Health Regulatory Agency (“ANVISA”), Health Canada, and Singapore Health Sciences Authority (“HSA”).

View the PDF to read the guidance.

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