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Cozen O'Connor

FDA Encourages Food Manufacturers to Phase Out FD&C Red No. 3 Ahead of 2027 Deadline

Cozen O'Connor on

On July 14, 2025, the Food and Drug Administration (FDA) issued new guidance encouraging food manufacturers to phase out FD&C Red No. 3 ahead of the previous 2027 deadline and “as soon as is practicably possible.” Recall...more

Womble Bond Dickinson

An Increasing Regulatory Maze for Nontraditional Meat Products

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As this blog has previously covered, various states have passed laws prohibiting plant-based products from being labeled like traditional meat products. A recent Oklahoma law bans using terms like beef, chicken, or bacon to...more

Kelley Drye & Warren LLP

FTC (and NAD) Celebrate ​“Made in USA” Month

On July 1, 2025, FTC Chairman Andrew Ferguson designated July as ​“Made in USA” Month. Chairman Ferguson noted that in a recent poll, 61% of Americans stated that whether a product was ​“Made in USA” played a factor in their...more

Hogan Lovells

FDA finalizes cyber device “select updates” guidance, potentially affecting substantial equivalence findings for 510(k)s

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently finalized its March 2024 select updates to its guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (“Premarket...more

Ropes & Gray LLP

FDA Finalizes Guidance on Remote Regulatory Assessments, But How Will They Support the Administration’s Manufacturing-Related...

Ropes & Gray LLP on

In response to travel restrictions imposed during the COVID-19 pandemic, the U.S. Food and Drug Administration (“FDA”) began conducting remote regulatory assessments (“RRAs”) of medical products companies and other...more

Littler

OSHA Renews its National Emphasis Program on Amputations in the Manufacturing Industry

Littler on

The U.S. Department of Labor’s Occupational Safety and Health Administration renewed its National Emphasis Program on Amputations in Manufacturing Industries (NEP) on June 27, 2025, superseding the prior version. This new NEP...more

ArentFox Schiff

FDA’s Remote Regulatory Assessments Enhance DSCSA Compliance With Technology-Driven Oversight

ArentFox Schiff on

On June 25, the US Food and Drug Administration (FDA) released a final guidance, “Conducting Remote Regulatory Assessments: Question and Answers.”...more

Gardner Law

FDA Finalizes Cybersecurity Premarket Guidance: What It Means for Medical Device Makers

Gardner Law on

The FDA has finalized its guidance on cybersecurity for medical device premarket submissions, providing additional insight into the agency’s expectations for how manufacturers integrate cybersecurity risk management into...more

Katten Muchin Rosenman LLP

FDA Requesting Comments on Proposed Guidance Regarding 510(k) Transfers

On June 5, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance (the “510(k) Transfer Guidance”) related to the transfer of a Premarket Notification (510(k)) Clearance. The 510(k) Transfer Guidance...more

MG+M The Law Firm

EPA Extends TSCA Section 8(d) Reporting Deadlines for Chemical Data Submissions

MG+M The Law Firm on

The US Environmental Protection Agency (EPA) has announced plans to extend the reporting deadlines for a rule under Section 8(d) of the Toxic Substances Control Act (TSCA). This rule mandates that manufacturers and importers...more

Hogan Lovells

New MDCG guidance clarifies rules for medical device software available on online platforms

Hogan Lovells on

The Medical Device Coordination Group (“MDCG”) has issued guidance on the safe making available of medical device software (“MDSW”) apps on online platforms (MDCG 2025-4). MDCG 2025-4 outlines the regulatory roles of online...more

Morrison & Foerster LLP

New Dietary Ingredient Notifications: FDA Addresses Common Pitfalls and Shares New Educational Tools

On June 11, 2025, the U.S. Food and Drug Administration (FDA) released educational videos and a new fact sheet to facilitate compliance with the agency’s New Dietary Ingredient Notification (NDIN) review process. Under the...more

Akin Gump Strauss Hauer & Feld LLP

FDA Adds a Dose of Clarity to the NDIN Process

Recently, the U.S. Food and Drug Administration (FDA) released two educational videos and a supplemental fact sheet to guide dietary supplement manufacturers and distributors through the New Dietary Ingredient Notification...more

Hogan Lovells

FDA finalizes 2025 Q-Submission Guidance, streamlining interactions for device sponsors and proposes electronic submission mandate...

Hogan Lovells on

On May 29, 2025, the U.S. Food and Drug Administration (FDA) issued a final version of its guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program,” offering an expanded framework...more

Hogan Lovells

Be vigilant: new post-market surveillance requirements for medical devices in Great Britain take effect

Hogan Lovells on

The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (PMSR), which were passed into law on 22 October 2024, came into force today (16 June 2025), amending the UK’s Medical...more

Hogan Lovells

FDA clarifies 510(k) clearance transfer rules in new Q&A guidance

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) announced new Q&A draft guidance on the “Transfer of a Premarket Notification (510(k)) Clearance,” which provides information on the most frequently asked questions regarding...more

BakerHostetler

FDA Issues Draft Guidance on Replacing Color Additives in Drug Products

BakerHostetler on

On May 27, 2025, the Food and Drug Administration (FDA) released a new draft guidance, “Replacing Color Additives in Approved or Marketed Drug Products” (Guidance), that outlines regulatory expectations for manufacturers and...more

Baker Donelson

HHS Previews Guidance Addressing Implementation of 340B Rebate System

Baker Donelson on

In the fall of 2024, several pharmaceutical companies reacted to HRSA's decision to prevent them from implementing a rebate model for their respective 340B Programs by filing lawsuits against HHS and HRSA claiming that the...more

Wiley Rein LLP

EPA Announces Major Actions on PFAS and the TSCA New Chemical Program

Wiley Rein LLP on

The U.S. Environmental Protection Agency (EPA) has published a much anticipated roadmap for how Administrator Lee Zeldin plans to address per- and polyfluorinated substances (PFAS) in the coming months. The announcement...more

Bergeson & Campbell, P.C.

EPA Provides Technical Support for Companies Submitting New Chemical Data

On April 25, 2025, the U.S. Environmental Protection Agency (EPA) announced the availability of new resources intended to help companies with the requirements described in EPA’s December 2024 final rule governing the review...more

Morgan Lewis

Key Messaging from ‘Aging Technology, Emerging Threats: Examining Cybersecurity Vulnerabilities in Legacy Medical Devices’

Morgan Lewis on

On April 1, 2025, the subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce held a hearing on cybersecurity vulnerabilities in legacy medical devices. The hearing was largely a...more

Stikeman Elliott LLP

Minor Updates, Major Message? The Competition Bureau Clarifies Guidance on “Made in Canada” and “Product of Canada” Claims

Stikeman Elliott LLP on

The Competition Bureau recently updated its Enforcement Guidelines for “Made in Canada” and “Product of Canada” claims, clarifying its approach to non-food products and highlighting new opportunities for private enforcement...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

Perkins Coie

FDA Releases Draft Guidance on the Labeling of Plant-Based Foods

Perkins Coie on

The U.S. Food and Drug Administration (FDA) recently published draft guidance on the Labeling of Plant-Based Alternatives to Animal-Derived Foods (Draft Guidance). The Draft Guidance recommends best practices for naming...more

Alston & Bird

FDA Publishes Guidance on Medical Device Shortages During Public Health Emergencies

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Our FDA/Food, Drug & Device and Health Care teams discuss new guidance from the Food and Drug Administration (FDA) on federal notification requirements for medical device manufacturing shortages during public health...more

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