The Justice Insiders Podcast: SEC Plays Chicken with Jarkesy
Podcast: Non-binding Guidance: A Discussion of Kisor v. Wilkie
Life sciences companies are adding risk factor language in response to the U.S. Supreme Court overturning the Chevron Doctrine. As you may recall, the U.S. Supreme Court recently overturned the Chevron Doctrine....more
For nearly 40 years, federal courts have been required to defer to an agency’s interpretation of an ambiguous statute, even if the court did not agree with that interpretation. This deference, commonly referred to as Chevron...more
The looming government shutdown will likely slow the pace of work at the FDA. The federal government will shut down on October 1, 2023 unless a deal is reached. In the event of a shutdown, 19% of FDA employees would be...more
U.S. Food and Drug Administration (FDA) Commissioner Robert Califf on Jan. 31, 2023, announced a proposed restructuring of the agency's Human Foods Program in an effort to improve coordination among the FDA offices. These...more
The U.S. Food and Drug Administration (FDA) has officially launched the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH) to expand the agency's activities in furtherance of its...more
This second McGuireWoods alert discussing regulation of hand sanitizer manufacture and distribution addresses new considerations from the Food and Drug Administration (FDA) published in a June 2020 update to its March 2020...more
On July 10, 2020, the U.S. Food and Drug Administration (FDA) announced that it will be restarting on-site prioritized domestic inspections, including food facilities, during the week of July 20 after pausing such inspections...more
LEGISLATION, REGULATIONS & STANDARDS - USDA Redistributes Responsibilities Among Agencies - The U.S. Department of Agriculture (USDA) has reallocated responsibilities between its agencies, resulting in the elimination...more
On June 20, 2018, the Food and Drug Administration (“FDA”) released draft guidance for companies required to comply with the FDA’s final rule, “Mitigation Strategies to Protect Food Against Intentional Adulteration” (“IA...more
On June 20, 2018, the FDA released draft guidance regarding the FDA’s Mitigation Strategies to Protect Food Against Intentional Adulteration Rule (IA Rule). This is the first of three installments of guidance the FDA plans...more