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FDA Signals Flexibility with COVID-19 Tests

A bipartisan group of experts in economics, health, technology, and ethics recommended that the U.S. scale up COVID-19 testing—5 million per day by June, 20 million per day by midsummer—in order to fully re-mobilize the economy. Consistent with this, FDA has taken various steps to accelerate the …›

May 11, 2020 - Trials

Status of Bay Area Jury Trials

On Thursday, May 7, the American Board of Trial Advocates sponsored a discussion with the presiding judges from five Bay Area counties: San Francisco, San Mateo, Contra Costa, Alameda, and Santa Clara. The panel addressed the current state of jury trials in the Bay …›

California Supreme Court: Civil Penalty Claims Brought by Government Under UCL and FAL Should Be Determined by Court—Not Jury

The California Supreme Court has confirmed that claims for civil penalties brought by government entities under California’s Unfair Competition Law (“UCL”)[1] and False Advertising Law (“FAL”)[2] should be decided by a judge—not a jury. See Nationwide Biweekly Administration Inc. et al. v. Superior Court …›

COVID-19 Update: FDA Authorizes First At-Home Collection Kit

FDA has been actively working to accelerate access to diagnostic tests for COVID-19 through its extension of Emergency Use Authorizations (EUAs). According to FDA Commissioner Stephen M. Hahn, M.D., “The FDA’s around-the-clock work since this outbreak began has resulted in the authorization of more …›

HHS Guidance Broadens PREP Act Immunity, Tightens Focus on Public/Private Cooperation

On April 14, the U.S. Department of Health and Human Services (HHS) issued an advisory opinion on the Public Readiness and Emergency Preparedness (PREP) Act to clarify the scope of immunity that accompanies developing and deploying countermeasures to COVID-19. The PREP Act grants tort liability …›