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Holland & Knight LLP

A MOSAIC of Changes: Recent FAA Actions Promote Advanced Air Mobility

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At the Experimental Aircraft Association's (EAA) annual EAA AirVenture Oshkosh, Wisconsin, on July 22, 2025, U.S. Department of Transportation Secretary Sean Duffy and Federal Aviation Administration (FAA) Deputy...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

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

Hogan Lovells

FDA announces expanded use of unannounced inspections at foreign manufacturing facilities

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On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced that it intends to expand its use of unannounced inspections at foreign manufacturing facilities. This announcement applies to facilities that produce...more

Blake, Cassels & Graydon LLP

Out-of-Sight and Oversight: Business Opportunities and Obligations of New Drone Regulations

Blake, Cassels & Graydon LLP on

In recent years, the drone (or remotely piloted aircraft system (RPAS)) industry has experienced rapid growth, particularly in commercial applications. As drones become integral to business operations, regulations must keep...more

Troutman Pepper Locke

FDA’s New Lead Guidelines: A Milestone for Safer Baby Foods

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In recent years, the safety of baby food has become a top priority for state attorneys general (AG) and federal agencies. In April 2021, the U.S. Food and Drug Administration (FDA) announced its “Closer to Zero” plan to...more

A&O Shearman

New CJEU ruling on the borderline between medicinal products and medical devices: Key takeaways

A&O Shearman on

The boundary between medicinal products and medical devices remains a recurring issue for companies developing or marketing borderline products and courts, which has already been the subject of numerous decisions. Recently,...more

Foley Hoag LLP

Congress Adds Some Teeth to FDA’s Authority to Regulate Cosmetics

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The Food and Drug Administration (FDA) now has additional regulatory authorities over cosmetics, thanks to the Food and Drug Omnibus Reform Act (FDORA). FDORA was a part of the Consolidated Appropriations Act, 2023 (the...more

Foley Hoag LLP - Cannabis and the Law

New York Bans Delta-8/Revises Hemp Regulations

Foley Hoag LLP - Cannabis and the Law on

New York, which only recently passed an ambitious adult-use cannabis bill, has also positioned itself as a leader in the field of hemp cannabinoid products, and just today, May 19, 2021, updated its regulations and standards...more

McDermott Will & Schulte

Digital Health in the United Kingdom: The New Regulatory Environment Under the Medical Device Regulation

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The MDR and other recent developments in the health care regulatory landscape pose new opportunities and challenges for medical software companies and investors in digital health in the United Kingdom. Although the regulatory...more

Mintz - Health Care Viewpoints

Paradigm Shift: Regulating Software as a Medical Device in the U.S.

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The U.S. Food and Drug Administration (FDA) is exploring the development of a new regulatory approach for software as a medical device (SaMD) that the agency believes will promote innovation while still assuring device safety...more

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