COVID-19 Update: FDA Authorizes First At-Home Collection Kit
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- 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... ›
MoFo Named #1 Producer of Quality Products-Liability Content
For the second year in a row, Morrison & Foerster has been named the “Top Firm” for Products Liability content by JD Supra’s 2020 Readers’ Choice Awards. The awards recognize just a single firm in each practice area. Erin Bosman , co-chair of the... ›Mental Health During COVID-19: FDA Waivers for Digital Health Devices
By: Jean Nguyen Ph.D.
As the number of days during which the U.S. remains under stay-at-home orders increases, the mental health of individuals has become a growing concern. Last week, the U.S. Food and Drug Administration (FDA) announced temporarily waiving certain requirements for digital health devices for treating... ›FDA Uses EUAs Broadly in the Fight Against COVID-19
By: Julie Y. Park
On February 4, 2020, the Secretary of the Department of Health and Human Services (HHS) determined, pursuant to section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act, that there is a significant potential for a public health emergency related to the novel... ›HHS Guidance Broadens PREP Act Immunity, Tightens Focus on Public/Private Cooperation
By: Erin M. Bosman and Julie Y. Park
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... ›CARES Act of 2020: Guide for Drug and Device Companies
The Coronavirus Aid, Relief, and Economic Security (CARES) Act (or “the Act”) is an unprecedented $2 trillion economic stimulus package passed to help mitigate the economic and health consequences caused by the COVID-19 pandemic and to strengthen the U.S. health system going forward. The... ›- - TCPA
More Autodialer Confusion: Second Circuit Decision Deepens Circuit Split
By: Adam J. Hunt and Michael G. Ahern
On April 7, 2020, the Second Circuit Court of Appeals vacated a district court’s decision granting summary judgment to a defendant in a TCPA class action and deepened a split among federal courts by holding that the systems the defendant used to send text... › CPSC Recall Remedies in the Time of COVID-19
By: Erin M. Bosman and Julie Y. Park
The Consumer Product Safety Commission (CPSC) recognizes that companies everywhere are in the midst of responding to the impact of COVID-19 on business operations, including government stay-at-home orders that could see some operations temporarily close. Given these “extraordinary circumstances,” the CPSC issued a notice... ›FDA Inspires Modifications and Quick Authorizations for Ventilators
By: Erin M. Bosman and Julie Y. Park
As the number of COVID-19 cases in the U.S. grows, the potential shortage of ventilators has become an increasing concern. This week, the U.S. Food and Drug Administration (FDA) took two important steps to keep medical facilities equipped with life-saving ventilators. Ventilator Modification Enforcement... ›Ninth Circuit Provides Guidance on Pre-certification Discovery
By: Claudia M. Vetesi
Earlier this year, the Ninth Circuit held that plaintiffs cannot avail themselves of liberal discovery rules in order to locate class representatives. The court found that Rule 26(b)(1) of the Federal Rules of Civil Procedure, which governs the discovery process, does not authorize discovery... ›