Perspectives on Food, Drug, Medical Device & Cosmetic

On March 7, 2022, the US Food and Drug Administration (FDA), operating under its New Animal Drug Authority, took a new, important regulatory step forward in assessing genome editing in animals. Specifically, the Agency announced a “low risk” determination and exercise of enforcement discretion.

As you know, in our recent Alert, we addressed the announcement of the members of the FCC’s Precision Agriculture Connectivity Task Force (“Task Force). Now, the FCC has announced the new members of the four “Working Groups” that will assist the Task Force in carrying out its work.

This week, FDA published a draft guidance on the use of registries to support regulatory decision-making, titled “Real-World Data: Assessing Registries to Support Regulatory Decision-Making or Drug and Biological Products.”

On November 18, 2021, just a few days before the Omicron variant suddenly revealed itself to the world, the preliminary results of two Phase III clinical trials were announced by AstraZeneca, bringing new hope to high-risk populations.

In this podcast, Brian Schneider and Megan Daily discuss frequently asked questions from small businesses and nonprofits about contract management.

On October 29, 2021, the FDA issued two Guidances that implement a new requirement of the federal Food, Drug, and Cosmetic Act (FDCA) that all registrants of drug establishments – both domestic and foreign – must file a report on the amount of each listed drug produced over the preceding year.

As critical product shortages arose during the early days of the COVID-19 pandemic, the Food and Drug Administration (FDA) issued guidance documents outlining temporary policies that allowed non-drug manufacturers to produce alcohol-based hand sanitizers and alcohol for use in such hand sanitizers.

The Pharmaceutical Research and Manufacturers of America (PhRMA) – a leading lobbying and advocacy group for drug manufacturers – has released an updated version of its “Code on Interactions with Health Care Professionals” (the PhRMA Code or the Code).

Sixty-nine Arent Fox LLP attorneys have been rated as leaders in their profession by The Best Lawyers in America 2022.

Hospitals have long used color-coded wristbands as a patient safety initiative. Recently, the FDA issued a letter to medical device manufacturers to caution them against using colors for device identification wristbands that could create confusion for clinicians and result in inappropriate medical

Since no COVID-19 vaccines have been granted regular FDA approval, the United States Department of Justice sought to clarify whether the vaccines’ EUA status prohibits the imposition of such requirements.

In a lawsuit filed on June 29, 2021, in Texas state court, a major national retailer alleges that a Texas law restricting its retail locations from selling liquor to consumers violates the Texas Constitution. The retailer is asking the court for a declaratory judgment that Section 22.16 of the Texa

On February 24, 2021, we first reported on the most significant variants of the novel coronavirus then emerging across the globe and here in the United States.

In July 2020, the Trump Administration issued an Executive Order (the EO) directing the Secretary of the Department of Health and Human Services (HHS) to take certain actions and finalize rulemakings designed to “support the goal of safe importation of prescription drugs.”

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.