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Manufacturers Risk Management

Bergeson & Campbell, P.C.

OECD Publishes Report on Commercial Availability and Current Uses of PFAS and Alternatives in Hydraulic Oils and Lubricants

On June 20, 2025, the Organisation for Economic Co-operation and Development (OECD) published a report entitled Per- and Polyfluoroalkyl Substances (PFAS) and Alternatives in Hydraulic Oils and Lubricants: Report on...more

Miller Canfield

Costly Claims: Corporations Confront the Consequences for Improper “Made in the USA” Claims

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The Made in the USA label carries significant marketing weight, especially in today’s political landscape, but it also comes with legal risks. Federal regulators and class action attorneys are scrutinizing origin claims,...more

Gardner Law

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

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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

MG+M The Law Firm

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

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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

King & Spalding

EUROPE - Navigating the Interplay Between EU AI Act and Medical Device Regulations: Strategic Update for the Healthcare Sectors

King & Spalding on

Already highly regulated with a risk-based approach at their core, AI-powered medical devices and in vitro diagnostic medical devices face new regulatory constraints stemming from the EU AI Act, a horizontal legal instrument...more

Bergeson & Campbell, P.C.

PPG Withdraws TSCA Section 21 Petition to Amend Final TCE Risk Management Rule for Specialty Polymeric Microporous Sheet Materials...

As reported in our May 13, 2025, blog item, on March 24, 2025, PPG Industries, Inc. (PPG) submitted a petition seeking an amendment to the U.S. Environmental Protection Agency’s (EPA) December 2024 final risk management rule...more

Holland & Knight LLP

EPA Extends TSCA Reporting Submission Deadline for 16 Substances

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The U.S. Environmental Protection Agency (EPA) finalized a rule to extend the deadline for manufacturers and importers of 16 chemicals to report certain unpublished health and safety studies to the EPA as required by a...more

McGuireWoods LLP

Retailers at Risk: FDA Issues Advisory on Recreational Nitrous Oxide Products

McGuireWoods LLP on

On June 4, 2025, the U.S. Food and Drug Administration issued a public advisory urging consumers not to inhale nitrous oxide (N2O) from commercial dispensers, including canisters, tanks and portable chargers. The advisory...more

Gardner Law

The Importance of a Clinical Trial Strategy

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Developing a medical product, such as a medical device, comes with important milestones that can cause a project to sink or swim. One major milestone is amassing the clinical data needed to support pre-market submissions....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

Bergeson & Campbell, P.C.

Clearing Regulatory Roadblocks: How Smarter Implementation Can Help Supply Chain Modernization

On June 5, 2025, the Joint Economic Committee (JEC) of the U.S. Congress convened a hearing titled “Barriers to Supply Chain Modernization and Factor Productivity Enhancements.” Throughout the hearing, members and witnesses...more

Bergeson & Campbell, P.C.

ACC Files TSCA Section 21 Petition Seeking Reconsideration of TCE Risk Management Rule

On May 27, 2025, the American Chemistry Council (ACC) petitioned the U.S. Environmental Protection Agency (EPA) under Section 21 of the Toxic Substances Control Act (TSCA) to reconsider the final risk management rule for...more

Bergeson & Campbell, P.C.

EPA Extends Deadline to Report Health and Safety Data for 16 Chemicals

The U.S. Environmental Protection Agency (EPA) issued a final rule on June 9, 2025, that extends the reporting deadlines for a rule under Section 8(d) of the Toxic Substances Control Act (TSCA) requiring manufacturers...more

Foley & Lardner LLP

Customs Fraud Makes the Big Leagues: DOJ’s New White-Collar Priorities Confirm Heightened Risk

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Last month, the Department of Justice put trade, customs, and tariff fraud squarely in the spotlight. This isn’t just another line item on the compliance checklist, it’s a loud-and-clear signal that import-related enforcement...more

Morris James LLP

Analyzing the Impact of Recent Studies Linking Depo-Provera to Increased Meningioma Risk

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Recent scientific research has uncovered a significant association between the long-term use of Depo-Provera, a widely used injectable contraceptive, and the development of meningiomas, tumors affecting the membranes...more

Shipman & Goodwin LLP

Federal Regulations Arriving ‘PFAShionably Late’ - A CBIA Manufacturing Spotlight Article

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A series of PFAS-related communications and rulemaking from the U.S. Environmental Protection Agency have recalibrated the agency’s focus areas and timeline under the second Trump administration. Federal PFAS regulation...more

Bergeson & Campbell, P.C.

TSCA Section 21 Petition Seeks Reconsideration of 2024 Rule Regarding Procedures for Chemical Risk Evaluation

On May 15, 2025, the Center for Environmental Accountability (CEA) filed a petition under Section 21 of the Toxic Substances Control Act (TSCA) requesting that the U.S. Environmental Protection Agency (EPA) reconsider the...more

Perkins Coie

Psychoactive Kratom Draws Continued Scrutiny and Legal Action

Perkins Coie on

In recent years, plaintiffs have increasingly set their sights on kratom, a controversial botanical supplement, as a target for litigation. With at least 15 putative class-action cases filed in the past year alone, this...more

Gardner Law

Staying Prepared Amid FDA Changes

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Despite recent staffing reductions and leadership transitions at the FDA, pharmaceutical and medical device manufacturers should not interpret these changes as a signal of reduced regulatory enforcement. On the contrary, the...more

Morrison & Foerster LLP

Proactivity in Product Safety: Best Practices for Compliance

Consumer product companies are facing unprecedented scrutiny as the Consumer Product Safety Commission (CPSC) intensifies its regulatory oversight. With heightened civil penalties, increased monitoring of e-commerce...more

Dentons

Ep. 63 – Speaking Fees and Safe Harbors: Lessons from a $202M AKS Settlement

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In April, a pharmaceutical manufacturer agreed to pay a $202 million settlement to resolve allegations of Anti-Kickback Statute (AKS) violations. At the heart of the case were speaker programs, where physicians and...more

Bergeson & Campbell, P.C.

EC Announces Low- and High-Risk Countries under the EUDR

The European Commission (EC) released on May 22, 2025, the identity of the countries that present a low or high risk of deforestation in producing seven commodities (cattle, cocoa, coffee, palm oil, rubber, soy, and wood)...more

Oberheiden P.C.

10 Critical Facts for Defense Logistics Agency (DLA) Contractors Facing Suspension or Debarment

Oberheiden P.C. on

The Defense Logistics Agency (DLA), is cracking down on procurement fraud and contract fraud. It has recently issued multiple referrals for suspension or debarment, and it is targeting not only prime vendors, but...more

Mitratech Holdings, Inc

EU Cyber Resilience Act: How to Prepare Now

The EU Cyber Resilience Act (CRA), adopted by the European Parliament in 2024, marks a major milestone in European cybersecurity legislation. As the first EU-wide law focused on the cybersecurity of digital products, it...more

Bergeson & Campbell, P.C.

EPA Receives TSCA Section 21 Petitions Seeking Reconsideration of Exemption Conditions in Final Trichloroethylene Rule

The U.S. Environmental Protection Agency (EPA) recently updated its website to include two petitions submitted under Section 21 of the Toxic Substances Control Act (TSCA) that seek reconsideration of exemption provisions of...more

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