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

Morrison & Foerster LLP

FDA Publishes Post-Market Assessment Tool to Rank Chemicals in Food Supply

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On June 18, 2025, FDA published a proposed “Post-Market Assessment Prioritization Tool” to guide how the agency plans to rank and prioritize food chemicals under its enhanced post-market review process. FDA’s unveiling of...more

Beveridge & Diamond PC

FDA to Overhaul Post-Market Chemical Review Program for Food Chemicals

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Key Takeaways - What Happened: The U.S. Food and Drug Administration (FDA) announced plans to update its food safety post-market chemical review program over the next few months to increase transparency and accelerate its...more

Dickinson Wright

Breaking: FDA, HHS Seek Public Input on Cutting Rules

Dickinson Wright on

On May 13, 2025, the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) announced a public Request for Information to “identify and eliminate outdated or unnecessary...more

Troutman Pepper Locke

FDA Proposes Limiting Nicotine Levels in Cigarettes and Certain Other Combusted Tobacco Products

Troutman Pepper Locke on

On January 15, the U.S. Food and Drug Administration (FDA) issued a proposed rule that would set a maximum nicotine level in combusted cigarettes and certain other combusted tobacco products....more

Jones Day

FDA Announces Proposed Rule Regarding Laboratory Developed Tests

Jones Day on

The highly anticipated rule, which would make explicit that LDTs are medical devices subject to FDA oversight, proposes to end the agency's general enforcement discretion approach to such devices....more

Nelson Mullins Riley & Scarborough LLP

FDA Revises Guidance Concerning Scientific Communications to HCPs about Unapproved Uses of Approved/Cleared Medical Products

Nelson Mullins Riley & Scarborough LLP on

The U.S. Food and Drug Administration (FDA) issued a long-awaited revised draft guidance on October 23, 2023, which focuses on communications to healthcare providers (HCPs) regarding scientific information on unapproved uses...more

Bass, Berry & Sims PLC

FDA Takes Definitive Step Toward the Regulation of LDTs

Bass, Berry & Sims PLC on

On October 3, the U.S. Food & Drug Administration (FDA) published a highly anticipated proposed rule (Proposed Rule) to regulate laboratory-developed tests (LDTs) as medical devices. LDTs are tests that are developed and...more

Morgan Lewis - Well Done

Salt-Shaking it Up: FDA Issues Proposed Rule to Allow Salt Substitutes in Standardized Foods

Morgan Lewis - Well Done on

FDA has consistently pursued its aim of encouraging US consumers to eat less salt. As we have previously written, FDA issued a Voluntary Sodium Reduction guidance in October 2021 to support the reduction of average sodium...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

Epstein Becker & Green

Unpacking Averages: Using NLP to Assess FDA’s Compliance with Notice and Comment in Guidance Development

Epstein Becker & Green on

Introduction - Let’s say FDA proposed a guidance document that would change the definition of “low cholesterol” for health claims. Now let’s say that when FDA finalized the guidance, instead of addressing that topic, FDA...more

Knobbe Martens

FDA Draft Guidance for Fostering Medical Device Improvement Using the Voluntary Improvement Program

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On May 5, 2022, the FDA’s Center for Devices and Radiological Health (CDRH) issued draft guidance regarding the FDA’s Voluntary Improvement Program (“VIP”). The draft guidance, Fostering Medical Device Improvement: FDA...more

Arnall Golden Gregory LLP

Roll With the Changes: FDA’s Proposed Amendments to Converge its Quality Management System Requirements With ISO Requirements

Arnall Golden Gregory LLP on

In the words of the rock band REO Speedwagon, from the 1978 song “Roll with the Changes,” “It had to happen, felt the tables turnin’.” Earlier this month, the Food and Drug Administration’s Device Good Manufacturing Practice...more

Hogan Lovells

FDA to test voluntary “healthy” symbols through consumer research

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The U.S. Food and Drug Administration (FDA) has recently signaled its continued interest in developing a voluntary “healthy” symbol for packaged foods as a representation of the nutrient content claim....more

Hogan Lovells

Unburden Yourself: FDA Requests Comments on Ways to Implement President Trump's Regulatory Reform Executive Orders

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Earlier this year, in an effort to alleviate unnecessary regulatory burdens, President Trump issued two executive orders, Executive Order 13771, Reducing Regulatory and Controlling Regulatory Costs and Executive Order 13777,...more

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