Insights on Food, Drug, Medical Device & Cosmetic

This updates our prior Alert regarding the importation and distribution of face masks and respirators to be used to meet the significant US health care challenges posed by the COVID-19 pandemic.

Arent Fox continues to monitor the FDA activities and scientific reports on COVID-19 and the novel coronavirus.

As we reported earlier this week, in an effort to increase the domestic supply of hand sanitizer, the US Food and Drug Administration (FDA) recently announced policies that temporarily relax certain requirements for the production of alcohol-based hand sanitizer.

FDA has issued a new Enforcement Policy that allows manufacturers of certain FDA-cleared non-invasive devices to expand their use for healthcare professionals to monitor patients remotely during the COVID-19 pandemic.

Arent Fox continues to monitor the latest scientific reports on COVID-19 and the novel coronavirus for issues that may be of general concern to our clients.  

FDA has issued a new Guidance to address certain challenges to clinical trials during the COVID-19 pandemic. This Guidance takes effect immediately and applies to clinical trials of drugs, biologics, and medical devices.

The coronavirus (COVID-19) outbreak has led to a dramatic increase in the demand for, and a shortage of, hand sanitizer in the US.

FDA has just issued what it calls “FAQs on Diagnostic Testing for SARS-CoV-2” that provides information on which tests and which testing laboratories have received Emergency Use Authorization for the testing for the COVID-19 virus.

FDA has just published a new Guidance that will allow for the suspension of reporting of certain adverse event reports while the COVID-19 pandemic continues.

News reports show that because of the spread of the novel coronavirus (COVID-19) pandemic, hospitals and medical facilities are overwhelmed and threaten to strain the healthcare system.

By now, almost everyone is aware of the dire situation that exists in the United States for testing patients with the Coronavirus.

Arent Fox has been monitoring daily updates from the top scientific journals and similar sources to get the most accurate information as soon as it is first made available. Here is a brief summary of the key issues that are of concern.

Arent Fox will host the Washington, DC Section of the Institute of Food Technologists’ 2020 Food Policy Impact meeting in February. Attorneys Karen Carr and Emily Leongini are scheduled to present.

Last month, Representatives Sean Patrick Maloney (NY-18) and Grace Meng (NY-6) introduced the Natural Cosmetics Act that would define the term “natural” as it relates to personal care products and give the US Food and Drug Administration (FDA) authority to enforce the new requirements. 

Food, Drug, Medical Device & Cosmetic attorney Emily Leongini will present at Q1 Production’s 7th Annual Food Labeling Regulatory Compliance Conference in February.

On October 18, Arent Fox’s New York office will host a one-of-a-kind event on behalf of the New York State Bar Association that focuses on the intersection of FDA and sports law.

WASHINGTON — Fifty Arent Fox LLP attorneys have been rated as leaders in their profession by The Best Lawyers in America 2020.

Life Sciences Counsel Stan Abramson will speak on a panel at a Farm Foundation Forum about the challenges and opportunities of implementing a new biotechnology regulation review process on July 23, 2019, at the National Press Club.

Life Sciences Partner Karen Ellis Carr will speak at the Farm Foundation® Forum, “Gene Editing: Opportunities and Challenges,” at the National Press Club on July 17, 2018.

Arent Fox LLP is pleased to announce the expansion of its nationally recognized Food, Drug, Medical Device & Cosmetic practice with the addition of Partner Deborah M. Shelton.

On June 6, the US Department of Agriculture (USDA or Agency) released its proposed revision to Part 340, the regulations implementing USDA’s authority over genetically engineered (GE) organisms, including GE plants.

Last week, USDA’s Agricultural Marketing Service convened a webinar to accept public comments on implementing the hemp provisions included in the 2018 farm bill.

Arent Fox hosted the Institute of Food Technologies and American Society for Nutrition’s 8th Annual Food Policy Impact meeting at the DC office on February 11-12th.

While he did not use a hemp pen like the one used by Senate Majority Leader Mitch McConnell (R-KY) to sign the conference report, President Trump signed into law the 2018 farm bill that includes a provision that legalizes hemp. Specifically, the provision would remove hemp from the federal list of c

Arent Fox FDA Associate Emily Leongini will present at CBI’s Bio/Pharma Compliance Congress on Non-promotional Activities.