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Manufacturers › Risk Assessment › Regulatory Requirements

Akin Gump Strauss Hauer & Feld LLP

FDA Moves Forward on Fluoropolymers

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On August 6, 2025, the U.S. Food and Drug Administration (FDA) became the latest governmental agency to confirm that fluoropolymers are both safe and necessary. After an independent safety review of fluoropolymers in medical...more

Williams Mullen

TSCA Test Marketing Exemption for New Chemicals: A Recent Case Study

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On July 24, 2025, U.S. Environmental Protection Agency (EPA) approved a Test Marketing Exemption (TME) under section 5(h)(1) of the Toxic Substances Control Act (TSCA) for a confidential new chemical substance (TME...more

Ropes & Gray LLP

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

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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

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

Bergeson & Campbell, P.C.

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

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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

Bergeson & Campbell, P.C.

Registration Open until May 16, 2025, for Joint Regulatory Risk Assessors Summit on Advancing Safety and Sustainability Assessment...

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On June 19 to June 20, 2025, the European Union (EU) Horizon Europe projects ACCORDs, iCare, MACRAMÉ, and nanoPASS are hosting a joint summit to address the needs of industry and regulators in assessing the safety and...more

Bergeson & Campbell, P.C.

Setting the Record Straight: New Chemical Review Needs Scientists

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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

Integral Consulting Inc.

Dermal Wipe Sampling for Semivolatile and Nonvolatile Flame Retardants

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The U.S. Toxic Substances Control Act (TSCA) plays a critical role in regulating chemicals to safeguard human health and the environment. Its 2016 amendment expanded the U.S. Environmental Protection Agency’s (EPA's)...more

Pillsbury Winthrop Shaw Pittman LLP

The EU’s Cyber Resilience Act: New Cybersecurity Requirements for Connected Products and Software

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The CRA will affect a broad range of digital products placed on the EU market (including by those based outside the EU), including connected hardware/devices, software and remote data processing solutions. The EU has adopted...more

Morgan Lewis

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

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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

Butler Snow LLP

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

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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

Alston & Bird

Manufacturers Take Note: FDA Clarifies In-Process Sampling Under Section 211.110

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Our FDA/Food, Drug & Device Team reviews how new draft guidance from the Food and Drug Administration (FDA) can help manufacturers better understand requirements for drug product manufacturing....more

Brooks Pierce

PFAS Regulatory Developments and Risk Considerations for Manufacturers 

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I. Overview of Federal Regulatory Developments Related to PFAS - Federal government activities with respect to regulation of PFAS in 2021, which will likely carry forward through 2024 include the following: ...more

Farrell Fritz, P.C.

Legislation Affecting the Pharmaceutical Industry

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During a year in which legislative activity was restrained by a variety of factors, most notably the Senate’s inability to maintain a consistent majority, the New York State Legislature nonetheless still passed 641 bills,...more

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