News & Analysis as of

Manufacturers Risk Management

Morris James LLP

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

Morris James LLP on

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

Shipman & Goodwin LLP on

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

Gardner Law on

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

Dentons on

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

J.S. Held

Beyond Safety & Effectiveness: Business Reasons to Prioritize Human Factors in Medical Device Design

J.S. Held on

To err is human. We have short attention spans and get distracted easily. We have unreliable memories and forget. We have a limited ability to process information, and we overgeneralize rules-of-thumb to the wrong situations....more

Baker Donelson

Executive Orders on Domestic Production of Critical Medicines and Biological Research Security

Baker Donelson on

What Happened? The President signed two companion Executive Orders (EO) on May 5, 2025 that collectively signal a significant federal pivot toward (i) accelerating the domestic manufacture of pharmaceuticals deemed "critical"...more

Bergeson & Campbell, P.C.

Setting the Record Straight: New Chemical Review Needs Scientists

On May 2, 2025, U.S. Environmental Protection Agency (EPA) Administrator Lee Zeldin announced the “[n]ext phase of organizational improvements to better integrate science into agency offices.” As part of this reorganization...more

Akin Gump Strauss Hauer & Feld LLP

EPA Speaks on PFAS: What Manufacturers Need to Know

After addressing a number of other programs over the first 100 days of the new administration, on April 28, 2025, the Environmental Protection Agency (EPA) finally addressed PFAS. Administrator Lee Zeldin outlined a number of...more

Hogan Lovells

AI Health Law & Policy: Comparing regulatory landscapes for AI in medical devices in the EU and U.S.

Hogan Lovells on

Artificial intelligence is transforming the medical device industry, offering unprecedented opportunities to enhance patient care. However, this technological leap comes with significant regulatory challenges. Across the...more

Alston & Bird

Addressing Data Integrity Challenges in Medical Device Submissions

Alston & Bird on

The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, valid data for medical device premarket submissions. Our FDA/Food, Drug & Device...more

Vedder Price

Taking Off: Financing the eVTOL Revolution

Vedder Price on

Imagine waking up in a peaceful, spacious community free from traffic and congestion, yet commuting quickly and comfortably into the bustling city center or directly to the airport within minutes. Picture military operations...more

BakerHostetler

[Podcast] A New World: Indemnification, Artificial Intelligence and Intellectual Property

BakerHostetler on

To describe the rise of artificial intelligence (AI) as rapid is a vast understatement. From its ubiquitous presence assisting us in our most mundane daily tasks to its warm embrace by business leaders eager to revolutionize...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

Mandelbaum Barrett PC

Tariffs Expected to Impact Construction Costs

Mandelbaum Barrett PC on

The Impact of Tariffs on Construction Costs - As construction costs continue to soar, the industry is bracing for even sharper increases in 2025. Tariffs on key materials—iron, steel, and lumber—are expected to drive up...more

Fenwick & West LLP

Intellectual Property in Heavy Manufacturing

Fenwick & West LLP on

Heavy manufacturing companies operate at the intersection of hardware, materials science, and automation—sectors where IP protection is critical for long-term competitive advantage. Unlike software startups, industrial...more

Hahn Loeser & Parks LLP

Construction Contracts for Manufacturing Facilities

The Federal Government’s recent imposition of tariffs appears designed largely to bring manufacturing back inside the United States. News reports indicate the Government understands that tariffs may initially cause pain but...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Contradicts Benzene Class Actions, Highlighting Risks of Third-Party Lab Testing

In March 2024, Valisure, an independent quality advocate, filed a citizen petition claiming to have detected elevated levels of benzene in benzoyl peroxide acne treatment products. Valisure’s petition included testing results...more

Butler Snow LLP

Turnabout is Fair Play – “Junk Science” Litigation Aftermath: Requisite Retractions and Dubious Do-Overs

Butler Snow LLP on

Do plaintiffs’ experts get to put junk science before juries more often than their opinions are excluded? The answer is a resounding “probably.” Even in light of the December 2023 amendment to Federal Rule of Evidence and its...more

243 Results
 / 
View per page
Page: of 10

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide