News & Analysis as of

Research and Development Rulemaking Process

Bergeson & Campbell, P.C.

EPA’s Office of Research and Development — Villain or Victim?

On July 18, 2025, the U.S. Environmental Protection Agency (EPA) rolled out the “reorganization plan” for its Office of Research and Development (ORD). The stated goal of the plan is to reduce budget expenditures, improve...more

Mintz - Antitrust Viewpoints

Federal Agencies Take Sweeping Action on AI in Accordance with AI EO — AI: The Washington Report (Part 2 of 2)

President Joe Biden’s October 2023 Executive Order on AI directed agencies to institute a significant number of actions on AI. On April 29, 2024, the White House announced that federal agencies had completed “all of the...more

Foley & Lardner LLP

ORI Proposes New Rulemaking for Research Misconduct Regulations

Foley & Lardner LLP on

On October 5, 2023, the Office of Research Integrity (ORI) of the Department of Health and Human Services (HHS) issued a notice of proposed rulemaking to update the Public Health Service (PHS) Policies on Research Misconduct...more

ArentFox Schiff

Environmental Justice Update: Five End-of-Year Lessons from EPA's 2022 Efforts

ArentFox Schiff on

The first two years of the Biden Administration have resulted in a seismic shift in terminology in the environmental space. Environmental justice (EJ), formerly viewed as a theoretical goal, has become unifying federal driver...more

McDermott Will & Schulte

Special Report - The Future of AI Regulation: The Government as Regulator and Research & Development Participant - Part 1 of 2

Artificial intelligence (AI) systems have raised concerns in the public—some speculative and some based in contemporary experience. Some of these concerns overlap with concerns about privacy of data, some relate to the...more

Hogan Lovells

Four new FDA guidances and proposed rule advance biosimilars policy framework

Hogan Lovells on

Yesterday, FDA released a series of guidances that aim to advance the agency’s biosimilars policy framework, along with a proposed rule on the definition of a “biological product,” which incorporates changes made by the...more

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