This week, FDA published a draft guidance on the use of registries to support regulatory decision-making, titled “Real-World Data: Assessing Registries to Support Regulatory Decision-Making or Drug and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 17, 2021, the Department of Defense (DoD) published an advanced notice of proposed rulemaking in connection with announced changes to the Cybersecurity Maturity Model Certification (CMMC) for the defense industrial base, styled “CMMC 2.0.”
The Centers for Medicare & Medicaid Services (CMS) calendar year 2022 rule finalizing changes to payment policies under the Physician Fee Schedule (PFS) and Medicare Part B (the Final Rule) was published on November 19, 2021. The Final Rule takes effect January 1, 2022.
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.
According to government regulators across the globe, everyone should have been acting to slow USD LIBOR use for the next six weeks. Except, of course, for the next six weeks…
Fashion brand, Thom Browne, has taken its trademark battle with Adidas overseas, urging a London court to cancel more than 20 of Adidas’s U.K. trademarks for its three-stripe design. This suit is part of an ongoing dispute between the brands that has spanned the globe for more than three years.
In this podcast, Brian Schneider and Megan Daily discuss frequently asked questions from small businesses and nonprofits about contract management.
Over the last few months, you may have seen more e-scooters on the streets as people have felt safer returning to schools and to the office, and have been gathering more frequently with family and friends. E-scooters have many potential benefits: they help alleviate traffic and city congestion.
A handful of recent court decisions have brought a small degree of resolution and simultaneously a large degree of uncertainty to what we at Arent Fox affectionately refer to as the “340B Saga.”
In this WorldSmart podcast, International Trade & Investment Practice Leader Kay Georgi discusses the current and future issues of export controls and economic sanctions, with International Group Co-Chairs Hunter Carter and Malcolm McNeil.
The US Department of Commerce’s Bureau of Industry and Security (BIS) has released more specific details on the operation of the new arrangement.
Last week, the EEOC again updated its COVID-19 technical assistance; this time, to include more information about employer retaliation in pandemic-related employment situations.
In this installment of the Five Questions, Five Answers podcast, Director of North American Manufacturing Birgit Matthiesen, Partner Angela Santos, and Associate Christine Hintze discuss the impact of US Customs’ crackdown on forced labor in company supply chains.
Headlines that Matter for Companies and Executives in Regulated Industries.
Arent Fox Automotive Practice Leader, Aaron Jacoby discusses market and legal trends and the impact on dealership facilities in this Automotive News “Daily Drive” edition.
The FCC announced that it will host a “virtual roundtable” on Monday, December 6, 2021, starting at 10:00 a.m. EST that will focus on the FCC’s “telehealth initiatives and the benefits they can bring to communities across the country.”
The Los Angeles District Attorney’s Office has ordered Kanye West’s Yeezy brand to pay $950,000 to settle a class action lawsuit claiming that the brand’s delayed shipping, and lack of notice thereof, is a violation of California’s 30-day shipping rules.
In recent months, new and modified Department of Commerce regulations impacting antidumping (AD) and countervailing duty (CVD) proceedings have taken effect.
In recent months, new and modified Department of Commerce regulations impacting antidumping (AD) and countervailing duty (CVD) proceedings have taken effect.
Apple is pushing to accelerate development of its electric car and is refocusing the project around full self-driving capabilities, according to people familiar with the matter, aiming to solve a technical challenge that has bedeviled the auto industry.
In recent months, new and modified Department of Commerce regulations impacting antidumping (AD) and countervailing duty (CVD) proceedings have taken effect.
In recent months, new and modified Department of Commerce regulations impacting antidumping (AD) and countervailing duty (CVD) proceedings have taken effect.
In recent months, new and modified Department of Commerce regulations impacting antidumping (AD) and countervailing duty (CVD) proceedings have taken effect.
In recent months, new and modified Department of Commerce regulations impacting antidumping (AD) and countervailing duty (CVD) proceedings have taken effect.
We have reported on OSHA Emergency Temporary Standard (“ETS”), published on November 5th, that mandates that covered employers require their employees to be fully vaccinated against COVID-19 or obtain weekly COVID-19 tests and wear a facemask in the workplace.