News & Analysis as of

Manufacturers Rulemaking Process

Venable LLP

Event in Review: The Modernization of Cosmetics Regulation Act of 2022

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The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the biggest change to the scope of the U.S. Food and Drug Administration's (FDA) regulatory authority over cosmetics since 1938. ...more

Environmental General Counsel PC

SB 54 _ California Selects CAA as PRO and Other Updates

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

Pierce Atwood LLP

PFAS In Maine: DEP Seeks Exemption Proposals

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The Maine Department of Environmental Protection (DEP) is now accepting proposals from entities that wish to obtain currently unavoidable use (CUU) designations under the PFAS in Products statute. This statute allows the...more

Robinson+Cole Manufacturing Law Blog

EPA Seeks Public Comment on Environmental Justice Guidance

The EPA is seeking comments on a newly released, revised guidance document regarding the consideration of environmental justice (EJ) concerns in the rulemaking process. The guidance document updates a 2016 version and...more

Latham & Watkins LLP

EPA Continues Its Phasedown of HFCs

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The agency’s two recent actions introduce enhanced restrictions on hydrofluorocarbons and provide a series of compliance dates for industry stakeholders. On October 5, 2023, the US Environmental Protection Agency (EPA)...more

Foley & Lardner LLP

Successfully Navigating EV Product Roll-Outs: Manufacturers Balance Innovation and Legacy Needs

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Automotive OEMs, suppliers, startups and other participants in the automotive ecosystem have a great deal to do in 2023 as manufacturers begin to move to diversify historical internal combustion engine (ICE) vehicle product...more

Gardner Law

The Evolving FDA Regulatory Landscape of Artificial Intelligence

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As artificial intelligence technology evolves on a seemingly minute-by-minute basis, the U.S. FDA’s regulatory approach continues to evolve in an effort to keep pace. “The promise of artificial intelligence in medicine is...more

Foley Hoag LLP

HRSA ADR Panel Dismisses NACHC's 340B Complaint Against Two Drug Manufacturers

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The 340B program requires drug manufacturers to offer outpatient pharmaceuticals to statutorily defined covered entities (including certain hospitals and certain federal grantees, such as federally qualified health centers)...more

ArentFox Schiff

US Drops New Export Controls on the Chinese Semiconductor, Advanced Computing, and Supercomputer Industries

ArentFox Schiff on

On Friday, October 7, 2022, the Bureau of Industry and Security (BIS) released an interim final rule containing an enormous set of export controls that will likely damage the Chinese semiconductor, advanced computing, and...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

Cozen O'Connor

A Glimpse Into OSHA Today and Tomorrow

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To state the obvious, the pandemic has resulted in completely unexpected change across the country in so many ways. OSHA’s visibility and role are probably one of the most significant changes to any federal agency. Prior to...more

Ervin Cohen & Jessup LLP

FTC Finalizes “Made in USA” Rule Amidst Inter-Commission Conflict

On July 1, 2021, the Federal Trade Commission (“FTC”) issued its final rule related to “Made in USA” and other unqualified U.S.-origin claims on product labels. The effective date of the rule is August 13, 2021....more

Foley & Lardner LLP

Right to Repair and the Biden Competition EO – What Manufacturers Need to Know

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Last week, President Biden issued an Executive Order on Promoting Competition in the American Economy. As my partner, Elizabeth Haas, points out, the antitrust implications are far reaching. Of the 72 different initiatives...more

Lathrop GPM

Far Reaching Executive Order Pushes Toward National “Right to Repair”

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President Biden signed into law on Friday, July 9, 2021, a sweeping executive order titled “Executive Order on Promoting Competition in the American Economy,” laying out 72 actions for more than a dozen federal agencies. The...more

Perkins Coie

“Made in America” Executive Order Calls for Expansion and Increased Oversight of Domestic Sourcing Requirements for Government...

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President Biden signed an executive order (EO) on January 25, 2021, outlining his administration’s policy to increase procurement of U.S.-made products by expansion of domestic preferences for American-made goods and...more

Seyfarth Shaw LLP

Seyfarth on CBD – February 2020 Update

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CBD continues to flourish in the markets despite lack of federal regulations, and we’ve identified some significant events that indicate there’s no sign it’s stopping. ...more

Pillsbury Winthrop Shaw Pittman LLP

EPA’s Wide-Ranging Rule on Perfluoroalkyl Substances

EPA continues its regulation of PFAS by shifting focus to the importation of certain PFAS-containing articles. - EPA goes for the low-hanging fruit by using TSCA to restrict the importation of long-chain PFAS that already...more

King & Spalding

FDA FY 2021 Budget Foretells Medical Device Cybersecurity Reform

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Increased premarket submission and post-market reporting requirements potentially on the horizon for high-tech devices. The Food and Drug Administration’s (“FDA’s”) budget proposal for FY2021 telegraphs FDA’s plan to seek new...more

Seyfarth Shaw LLP

Sad Day for Coupon-Clippers

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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

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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

Robinson+Cole Manufacturing Law Blog

A Look Back and Ahead: 2020 Employment Law Predictions

Our tradition includes using our first January post to make predictions about “what’s to come” in the year ahead.  But first, let’s see how I did over the last year.  “Time for 2019 Manufacturing Law Predictions:  Drum Roll...more

Seyfarth Shaw LLP

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

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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

Stinson - Government Contracting Matters

Final FAR Rule Mandating GIDEP Reporting of Actual or Suspected Counterfeit Parts Issued: More Questions Than Answers

Supply chain risks are on the rise. Protecting the supply chain is a critical aspect of our national security, health and public safety. Whether parts are electronic or not, if they aren’t what they are represented to be,...more

Robinson+Cole Manufacturing Law Blog

For Manufacturers, “It’s Déjà Vu All Over Again!”

[With apologies to the great Yogi Berra!] Over the last three years, I have spent a good bit of space on this blog keeping manufacturers informed of the Department of Labor’s efforts to raise the wages of lower and middle...more

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