Insights on Food, Drug, Medical Device & Cosmetic

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.

Partner Karen Carr and Associate Emily Leongini will participate as speakers at the 3rd Annual Dietary Supplement Regulatory Strategy Conference in December 2018.

NEW YORK – Earlier this year, Yeshiva University’s Katz Graduate Business School introduced a new 36-credit Master of Science in Biotechnology Management and Entrepreneurship designed to prepare future business leaders in the life sciences to successfully navigate the launching new medical drugs.

Brian Ronholm, Senior Director of Regulatory Policy, and Emily Leongini, Associate, will present at FoodSafety Tech’s 2018 Food Safety Consortium.

WASHINGTON — Twenty-four Arent Fox LLP practices have been recognized in the 2019 “Best Law Firms” rankings that are published annually by US News & World Report and Best Lawyers.

The Department of Health and Human Services (HHS) has issued a proposed rule (PR) which would require any television advertisement for a drug or biological covered by Medicare or Medicaid to include a disclosure of the product’s “current list price” for a “typical” thirty day supply.

President Trump signed into law a bill that expands the Open Payments reporting requirements.

Partner Karen Carr will moderate the panel “Upcoming USDA Bioengineered Food Regulations” at FDLI’s Food Advertising, Labeling, and Litigation Conference on September 26-27 at Covington & Burling LLP in Washington, DC.

Forty Arent Fox LLP attorneys have been rated as leaders in their profession by The Best Lawyers in America 2019.

Earlier this week the Court of Justice of the European Union, the EU’s highest court, issued a decision clarifying whether the EU would regulate products of innovative breeding techniques, like gene editing, under the EU’s Directive 2001/18, the principal EU law governing the regulation of GMOs.