News & Analysis as of

Manufacturers Rulemaking Process Comment Period

Williams Mullen

EPA Considers New TSCA Rules for Common Solvent PCE

Williams Mullen on

On July 30, 2025, the U.S. Environmental Protection Agency (EPA) issued a request for public comment on the potential regulation of perchloroethylene (PCE) under the Toxic Substances Control Act (TSCA). PCE is a widely used...more

Shipman & Goodwin LLP

340B Drug Pricing Program Is on a Slippery Slope

Shipman & Goodwin LLP on

On July 31, 2025, notice was published in the Federal Register by the Health Resources and Services Administration (“HRSA”) of a “340B Rebate Model Pilot Program” (“340B Pilot Program”). The 340B Pilot Program’s stated...more

Bergeson & Campbell, P.C.

Minnesota Extends Public Comment Period on Proposed PFAS Reporting Rule as Entities Voice Concerns about Compliance with Deadlines...

On May 22, 2025, the Minnesota Pollution Control Agency (MPCA) held a public hearing on its “Proposed Permanent Rules Relating to PFAS in Products; Reporting and Fees” (proposed rule). Administrative Law Judge (ALJ) Jim...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Proposes Amendments to Medical Device Quality System Regulation

On February 22, 2022, the Food and Drug Administration (FDA) proposed a long-awaited rule to amend its Quality System Regulation (QSR), which is codified at 21 CFR Part 820 and sets forth current good manufacturing practice...more

Seyfarth Shaw LLP

Sad Day for Coupon-Clippers

Seyfarth Shaw LLP on

Seyfarth Synopsis: Recently, the Trump Administration issued its proposed Notice of Benefit & Payment Parameter for 2021 regulations....more

Hogan Lovells

EU Commission seeks feedback on implementing the new Market Surveillance Regulation

Hogan Lovells on

The European Commission announced on 22 January 2020 that it is looking for feedback on draft guidelines on the implementation of Article 4 of the Market Surveillance Regulation (EU) 2019/1020 (the "Regulation"). ...more

Seyfarth Shaw LLP

NDAttention – National Defense Authorization Act (NDAA) Adds Per- and Polyfluoroalkyl Chemicals to TRI

Seyfarth Shaw LLP on

Seyfarth Synopsis: On December 20, 2019, the National Defense Authorization Act for Fiscal Year 2020 (NDAA) was signed into law, including provisions for adding certain per- and polyfluoroalkyl substances (PFAS) to the EPA’s...more

Robinson+Cole Manufacturing Law Blog

PFAS Update: EPA Progress Under PFAS Action Plan

Earlier this year, we wrote about EPA’s PFAS Action Plan, the agency’s blueprint for addressing contamination and protecting public health from per- and polyfluoroalkyl substances (PFAS). ...more

Robinson+Cole Manufacturing Law Blog

New DOL Overtime Rule Impacts Manufacturers

The United States Department of Labor finally published its proposed regulation raising the minimum salary to be paid under the “white collar” exceptions to the Fair Labor Standards Act....more

McDermott Will & Schulte

TTB Reopens Comment Period for Three Notices of Proposed Rulemaking

McDermott Will & Schulte on

On October 11, 2017, the Alcohol and Tobacco Tax and Trade Bureau (TTB) reopened the comment period for the following three notices of proposed rulemaking... ...more

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