News & Analysis as of

Draft Guidance Trump Administration

McDermott Will & Emery

Preparing for 2025: Key Trends in FDA Guidance Agendas

McDermott Will & Emery on

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

DLA Piper

Trump Administration’s DEI Executive Order and the Impact on FDA’s DAP Draft Guidance: Top Points

DLA Piper on

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

Benesch

Proposed Elimination of Cumulative Effects Analysis under NEPA Leaves Climate Change Considerations in Jeopardy

Benesch on

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

Akin Gump Strauss Hauer & Feld LLP

Trump Administration Issues Proposed Policies to Facilitate Importation of Prescription Drugs from Canada, Other Countries

• 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 • In addition, FDA issues draft guidance for industry to explain how drug manufacturers can import their own...more

King & Spalding

Taking Cues from Justice Department, New Executive Orders Limit Agency Use of Guidance to Establish and Enforce Regulatory Policy

King & Spalding on

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

Mitchell, Williams, Selig, Gates & Woodyard,...

October 9th White House Executive Orders: Administrative Enforcement/Agency Guidance Document

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

(ACOEL) | American College of Environmental...

Calling Off the NEPA Hounds – The CEQ’s 2019 Draft Guidance on GHG Emissions

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

Hogan Lovells

State Department signals increased focus on surveillance technology and human rights abuses

Hogan Lovells on

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

Perkins Coie

Trump Administration Issues Draft Guidance on Greenhouse Gas Emissions Evaluation Under NEPA

Perkins Coie on

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

Miles & Stockbridge P.C.

EPA Guidance Documents Are Not Enforceable Rules Says DOJ

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

Downey Brand LLP

Draft 408 Guidance imminent; USACE Webinars Scheduled

Downey Brand LLP on

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

Knobbe Martens

FDA Issues Draft Guidance for "Least Burdensome” Approach to Device Regulation

Knobbe Martens on

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

Proskauer - Law and the Workplace

DOL Withdraws Obama-Era Administrator’s Interpretations on Independent Contractors and Joint Employment

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

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