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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

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

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

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

Alston & Bird

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

Alston & Bird on

Our FDA/Food, Drug & Device Team reviews how new draft guidance from the Food and Drug Administration (FDA) can help manufacturers better understand requirements for drug product manufacturing....more

Akin Gump Strauss Hauer & Feld LLP

International Trade Impacts of The Coronavirus: Update On Government And Industry Actions And Key Considerations For Trade...

Akin Gump Strauss Hauer & Feld LLP on

The new coronavirus, SARS-CoV-2, and the disease it causes, COVID-19, have created diverse, complex, and immediate challenges for world governments, multinational businesses, and other international institutions and projects....more

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