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DLA Piper

Microplastics Proposed for Candidate Chemical Listing in California: Key Considerations for Businesses

DLA Piper on

California’s Department of Toxic Substances Control (DTSC) proposed adding microplastics as a Candidate Chemical to be regulated under the Safer Consumer Products (SCP) program on June 20, 2025. This action and its subsequent...more

Katten Muchin Rosenman LLP

FDA Requesting Comments on Proposed Guidance Regarding 510(k) Transfers

Katten Muchin Rosenman LLP on

On June 5, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance (the “510(k) Transfer Guidance”) related to the transfer of a Premarket Notification (510(k)) Clearance. The 510(k) Transfer Guidance...more

Hogan Lovells

FDA finalizes 2025 Q-Submission Guidance, streamlining interactions for device sponsors and proposes electronic submission mandate...

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On May 29, 2025, the U.S. Food and Drug Administration (FDA) issued a final version of its guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program,” offering an expanded framework...more

Cozen O'Connor

HHS Advocates Mandated Placebo-Controlled Trials for New Vaccines: Implications for Clinical and Regulatory Practice

Cozen O'Connor on

The Department of Health and Human Services (“HHS”) recently proposed a policy that would require all new vaccines to undergo placebo-controlled clinical trials prior to FDA approval. The proposal, while controversial, is...more

Morrison & Foerster LLP

So Long, CPSC?

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The Trump administration may eliminate the Consumer Product Safety Commission (CPSC), according to a recently leaked draft fiscal year 2026 budget for the Department of Health and Human Services (HHS). This “pre-decisional”...more

Troutman Pepper Locke

11 AGs Sign Letter in Support of GSA’s Proposed Rule on Plastic Packaging

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The U.S. General Service Administration (GSA) proposed an amendment to the General Services Acquisition Regulation (GSAR) aimed at reducing single-use plastic packaging. Specifically, the proposed amendment allows suppliers...more

Environmental General Counsel PC

SB 54 _ California Selects CAA as PRO and Other Updates

Environmental General Counsel PC on

Within the last month, California has made significant strides toward its bid to create a circular economy for certain packaging and food service ware materials. On January 8, 2024, California's Department of Resources...more

McDermott Will & Schulte

FDA Issues Proposed Rule to Amend Medical Device Quality System Regulation

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The US Food and Drug Administration (FDA) published its Medical Devices; Quality System Regulation Amendments proposed rule to amend the medical device Quality System Regulation (QSR) on February 23, 2022. While FDA generally...more

Hogan Lovells

Legislative and Regulatory Update on Federal Supply Chain Risk Management

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The U.S. Government is renewing its focus on mitigating technological risks by regulating the supply chain for various goods and services. ...more

Foley & Lardner LLP

NHTSA and Motor Vehicle Safety

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The closing years of the Obama administration saw a whirlwind of regulatory activity from NHTSA, including multiple consent orders, record penalties, and soaring recall numbers. The more aggressive enforcement posture, hailed...more

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