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.
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.
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.
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.
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.
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
NEWYORK – 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.
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.
Arent Fox Intellectual Property Partner Alex Spiegler and FDA Associate Emily Leongini will present at the International Bar Association (IBA) 6th Annual World Life Sciences Conference.
Arent Fox will host the reception for the New York State Bar Association’s (NYSBA’s) Food, Drug & Cosmetic Law Section Annual Meeting on January 25th, 2018 in its New York office.
The White House issued an executive order on January 30, 2017 requiring agencies and executive departments to “identify at least two existing regulations to be repealed” whenever they propose or promulgate a new regulation.