Insights on Food, Drug, Medical Device & Cosmetic

We have seen biopharmaceutical companies around the world working to tackle COVID-19 in vaccine development, treatment development, and diagnostics, including the creation of world-class vaccines in record time, rapid tests for home use, and effective treatments against this novel virus.

On April 19, 2021, FDA issued a final rule that amends its device classification regulations to exclude from regulation as a medical device certain types of software functions for certain products.

Partner Brian Waldman is a featured speaker in this year’s opening webinar of the Healthcare Distribution Alliance’s Traceability Webinar Series.

Food, Drug, Medical Device & Cosmetic Counsel Wayne Matelski will present at UT Law CLE’s annual Health Law Conference on April 8, 2021.

As we explained in a previous alert, one of the lesser-known provisions of the March 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act was a significant overhaul of the way that most OTC drugs are regulated in the United States.

We have seen biopharmaceutical companies around the world partnering to tackle COVID-19 in diagnostics, treatment development, vaccine development, and other relief efforts, including monetary and in-kind donations of lab equipment, instruments, and personal protective equipment (PPE).

It covers both single-use (disposable) and reusable products for use by workers and by the general public.

FDA has been monitoring the emergence of novel coronavirus mutations and variants and their potential for impacting the results of currently authorized COVID-19 tests.

FDA provides requirements that will allow for a much quicker authorization of “booster shots” for existing vaccines for use against variants or mutations of the coronavirus.

The novel coronavirus undergoes a mutation about once every 2 weeks, or half the rate seen in influenza.

Recent legislative developments include amendments to expand upon Orange Book and Purple Book listing requirements.

Hemp flower growers and smokable hemp manufacturers impacted by state laws that have banned or restricted smokable hemp flower production and sales are worried that federal regulators could echo state-level restrictions on a national scale.

Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., No. 19-CV-06593 (N.D. Cal. Oct. 16, 2020).

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.