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Manufacturers › Regulatory Oversight › Risk Assessment

Bergeson & Campbell, P.C.

EPA Accelerates Review of LVEs

Bergeson & Campbell, P.C. on

The U.S. Environmental Protection Agency (EPA) announced on August 11, 2025, the results of process improvements to accelerate the review of Low Volume Exemptions (LVE) in the Toxic Substances Control Act (TSCA) New Chemicals...more

Akin Gump Strauss Hauer & Feld LLP

FDA Moves Forward on Fluoropolymers

Akin Gump Strauss Hauer & Feld LLP on

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

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

Bergeson & Campbell, P.C.

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

Bergeson & Campbell, P.C. on

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

Alston & Bird

D-Day for the EU Cyber Resilience Act

Alston & Bird on

Our Privacy, Cyber & Data Strategy Team discusses the new Cyber Resilience Act (CRA) that affects manufacturers and distributors of connected devices that are in use anywhere in the European Union....more

K&L Gates LLP

Increasing Regulatory Scrutiny of Formaldehyde Under TSCA

K&L Gates LLP on

Companies using formaldehyde in their manufacturing processes and/or selling products incorporating formaldehyde-containing components from upstream suppliers face significant challenges in an evolving regulatory landscape....more

Downey Brand LLP

EPA’s Final Rule Enhances Risk Evaluations Process For Scrutiny of TSCA Chemicals

Downey Brand LLP on

On May 3, 2024, the Environmental Protection Agency (EPA) published its Final Rule that amends the risk evaluation process for chemicals under the Toxic Substances Control Act (TSCA) and the steps chemical manufacturers and...more

K&L Gates LLP

Brussels Regulatory Brief: April 2024

K&L Gates LLP on

Antitrust and Competition - European Commission Charges Company with Providing Incorrect, Incomplete, and Misleading Information During a Merger Control Proceeding - On 19 March 2024, the European Commission (Commission) sent...more

Dorsey & Whitney LLP

AI regulation introduced in Europe - setting the way forward for the rest of the world or slowing down the adoption of new tech?

Dorsey & Whitney LLP on

The EU AI Act, which was passed by the European Parliament on 13 March and is set to become law later this year, will probably be the world’s first legislation to introduce a general regulatory framework for artificial...more

K&L Gates LLP

Brussels Regulatory Brief: February 2024

K&L Gates LLP on

Antitrust and Competition - The European Commission Carried Out Unannounced Inspections in the Tires Sector - On 30 January 2024, the Commission conducted dawn raids at the premises of several companies active in the tires...more

Farrell Fritz, P.C.

Legislation Affecting the Pharmaceutical Industry

Farrell Fritz, P.C. on

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

Thomas Fox - Compliance Evangelist

Four Things Compliance Practitioner Should Know About the Eurasian Economic Union

Thomas Fox - Compliance Evangelist on

Four Things Compliance Practitioner Should Know About the Eurasian Economic Union - An effective Compliance risk management at emerging markets for any business significantly depends on timeous observation of changes in...more

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