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Regulatory Reform › Public Comment › Food and Drug Administration (FDA)

Morgan Lewis - Well Done

FDA Proposes New Tool for Post-Market Scientific Assessment of Food Ingredients

Morgan Lewis - Well Done on

On June 18, 2025, FDA announced for public comment a Post-market Assessment Prioritization Tool (Prioritization Tool) as an enhanced systematic process for post-market scientific assessment of chemicals in food, including...more

Holland & Knight LLP

FDA Initiates New Post-Market Review Framework for Food Chemicals

Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) has announced a new initiative to systematically review the safety of chemicals already in the nation's food supply....more

Gardner Law

FDA Guidance for Labeling Plant-based Products

Gardner Law on

The FDA has developed draft guidance addressing confusion and legal action over the naming and labeling of plant-based alternatives to eggs, seafood, poultry, meat and dairy (excluding plant-based milk, e.g. oat milk). FDA is...more

Epstein Becker & Green

HHS Reverses Its Longstanding Policy and Limits Public Participation in Rulemaking

Epstein Becker & Green on

On March 3, 2025, the Secretary of Health and Human Services published a policy statement in the Federal Register that reverses a policy adopted over 50 years ago that was intended to expand public participation in the...more

Nelson Mullins Riley & Scarborough LLP

FDA Publishes Groundbreaking AI/ML Medical Device Draft Guidance

Nelson Mullins Riley & Scarborough LLP on

The U.S. Food and Drug Administration (“FDA”) has announced its first-ever draft guidance specifically addressing the use of artificial intelligence/machine learning (“AI/ML”) in medical devices (“Draft Guidance”).This...more

Nelson Mullins Riley & Scarborough LLP

FDA Revamps Guidance Concerning Use of Electronic Systems, Records, and Signatures in Clinical Investigations

Nelson Mullins Riley & Scarborough LLP on

The U.S. Food and Drug Administration (FDA) has published updated draft guidance for industry, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations–Questions and Answers (Draft...more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FDA Issues Draft Guidance for "Least Burdensome” Approach to Device Regulation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The FDA recently issued a draft guidance document intended to “to ensure that least burdensome principles are implemented for all device-related applications and interactions with FDA.”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

Mintz - Health Care Viewpoints

FDA Takes First Steps to Cut Regulations, Solicits Public Feedback

Mintz - Health Care Viewpoints on

Since our March 17th post about President Trump’s executive actions aiming to implement his deregulatory agenda, several important developments related to the so-called “2-for-1” Executive Order (E.O. 13,771) have occurred...more

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