Medical Device Legal News with Sam Bernstein: Episode 11
In January 2025, various US Food and Drug Administration (FDA) centers and offices published their guidance agendas for the 2025 calendar year (CY). These agendas provide valuable insights into FDA’s regulatory priorities,...more
For more than a decade, the Food and Drug Administration (FDA) has made diversity in clinical trials a focus, including by issuing guidance, convening public-private workshops, and completing data analyses in an effort to...more
On January 9th, President Donald Trump in conjunction with the Council on Environmental Quality (“CEQ”) proposed sweeping regulatory revisions to rules that govern how the CEQ implements the National Environmental Policy Act...more
• FDA issues a Proposed Rule to allow states and other entities to import certain prescription drugs from Canada. • In addition, FDA issues draft guidance for industry to explain how drug manufacturers can import their own...more
On October 9, 2019, President Trump signed two executive orders: Promoting the Rule of Law Through Improved Agency Guidance (Executive Order 13891) (the “Guidance Executive Order”) and Promoting the Rule of Law Through...more
The White House on October 9th issued two executive documents that are relevant to federal environmental enforcement: Executive Order on Promoting the Rule of Law Through Transparency and Fairness and Civil Administrative...more
On June 26, 2019, the Council on Environmental Quality (CEQ) published a Draft National Environmental Policy Act Guidance on Consideration of Greenhouse Gas Emissions (84 Fed. Reg. 30097). This new guidance would replace the...more
On 4 September 2019 the U.S. State Department issued "Draft 'U.S. Government Guidance for the Export of Hardware, Software and Technology with Surveillance Capabilities and/or parts/know-how'" (draft guidance). ...more
The Council on Environmental Quality published draft guidance June 26, 2019, on how to assess greenhouse gas emissions under the National Environmental Policy Act, the law that requires environmental impact assessment for...more
Companies regulated by the Environmental Protection Agency (EPA) have long complained that EPA too often uses guidance documents improperly, both to expand regulatory requirements beyond what the law permits and to avoid...more
Happy New Year!!!!!! Yes, it is actually February, but it is a new year for this blog as we turn our attention to a world full of flood risk reduction actions in the second year of the Trump Administration. We are hearing...more
The FDA recently issued a draft guidance document intended to “to ensure that least burdensome principles are implemented for all device-related applications and interactions with FDA.” The FDA provides this draft guidance...more
Employers across the U.S. were troubled by the sub-regulatory guidance issued by the DOL in 2015 and 2016 on independent contractors and joint employment. Today, the DOL announced the withdrawal of that guidance...more