Insights on Food, Drug, Medical Device & Cosmetic

Late yesterday, November 17, 2020, the FDA issued an Emergency Use Authorization (EUA) to Lucira Health for an All-In-One Test Kit for prescription home use in individuals 14 years of age or older.

Twenty-four Arent Fox LLP practices have been recognized in the 2021 “Best Law Firms” rankings that are published annually by US News & World Report and Best Lawyers.

The FDA announced on October 7 that it will no longer review requests for Emergency Use Authorizations (EUAs) for COVID-19 laboratory developed tests – so called “LDTs.” This is a substantial change in Agency policy.

Partner Karen Carr will serve as a panel speaker at the 2020 FDLI Annual Conference in October. Karen’s session is titled “Emerging Technologies: Regulatory Oversight of Intentional Genomic Alterations in Animals.”

Last week FDA published a proposed rule that would revise the agency’s “intended use” regulations to clarify that a manufacturer’s knowledge of off-label use of its drug or device is, by itself, not sufficient to establish a violation of the Food, Drug, and Cosmetic Act (FDCA).

On August 24, the US Environmental Protection Agency announced a groundbreaking development in efforts to combat COVID-19.

In the Food and Drug area, we don’t often get dramatic changes in FDA policies, but an announcement from the Secretary of HHS, published on August 18, appears to be just such a dramatic change.

Fifty-three Arent Fox LLP attorneys have been rated as leaders in their profession by The Best Lawyers in America 2021.

The United States Trademark Trial and Appeal Board (TTAB) recently affirmed a refusal to register a trademark for “hemp oil extracts” when used as an ingredient in dietary supplements.

The FDA has just issued a Guidance on what it considers to be appropriate Current Good Manufacturing Practices (CGMPs) for Responding to COVID-19 infections in employees in drug and biological manufacturing facilities. 

FDA’s website allows you to determine if a particular COVID-19 test has been reviewed by the FDA.

On June 10, 2020, the FDA issued an emergency use authorization (EUA) for the first molecular diagnostic test that can generate information about the genomic sequence of the COVID-19 virus.

AgTech Partner Karen Carr recently participated in a webinar about the US Department of Agriculture’s final rule addressing regulation of agricultural biotechnology products issued on May 15, 2020.

FDA has yet again revised its Enforcement Policy for the US importation and distribution of face masks and respirators during the COVID-19 pandemic.

The FDA has just published a list of certain already-on-the-market serology/antibody tests from commercial manufacturers that should not be distributed unless and until an Emergency Use Authorization (EUA) is issued for the test.

On Friday, May 22, 2020, the USDA and FDA jointly released recommendations to address shortages of personal protective equipment (PPE), cloth face coverings, disinfectants, and sanitation supplies in the food and agriculture industries.

“Testing, Testing, Testing” is the new mantra. The politicians and the press are full of the few reports of testing successes and the many reports of testing failures throughout the country and around the world.

On May 8, 2020, the FDA announced that it had authorized the first COVID-19 diagnostic test that can be used to collect saliva in the home.

What one hand giveth, the other can taketh away. That adage comes to mind when reviewing FDA’s most recent action with respect to the importation and distribution of KN95 and other respirator masks manufactured in China. 

The presence in the blood of antibodies specific to the novel coronavirus may help identify those who were unknowingly exposed to the virus but remained asymptomatic, those who were symptomatic but have fully recovered, and, as a result, those who might now have immunity, at least temporarily. Howev

On May 4, 2020, the FDA issued new Guidance that drastically changes the requirements for serology/antibody tests for the COVID-19 epidemic.

Chambers USA: America’s Leading Lawyers for Business has recognized 29 Arent Fox LLP attorneys as leaders in their field.

This updates our prior Alerts regarding the importation and distribution of face masks during the COVID-19 pandemic. The daily news is replete with reports of various types of masks and other personal protective equipment (PPE) that pose supply challenges due to high demand.

For years, regulators, industry, and lawmakers alike have sought to modernize the regulatory framework under which most over-the-counter (OTC) drugs are marketed in the US. With the enactment of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) on March 27, 2020.

As the United States begins to see positive signs that mitigation efforts such as stay-at-home orders and social distancing are working, the question of when people can return to work and resume normal activities is one of the most critical issues facing the country – and indeed the world.