News & Analysis as of

Manufacturers Transparency

Saul Ewing LLP

State Food Policy Heat Wave

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Background - As temperatures have heated up this summer, so has the pace of new state food policies. Over the past several weeks, there has been an uptick in the promulgation of bans on food additives and laws aimed at...more

MoFo Life Sciences

HHS Secretary to FDA: Consider Elimination of GRAS Self-affirmation Pathway

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On March 10, the U.S. Department of Health and Human Services (HHS) issued a press release emphasizing “radical transparency to make sure all Americans know what is in their food” and announcing that HHS Secretary Robert F....more

Cozen O'Connor

The State AG Report – 12.19.2024

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Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: •Illinois AG’s and FTC’s Settlement Takes a $25 Million...more

Cozen O'Connor

NJ Adopts More Transparent Prescription Drug Pricing

Cozen O'Connor on

New Jersey AG Matthew Platkin announced the adoption of new rules designed to promote greater transparency in prescription drug pricing. The new rules implement recently enacted legislation intended to control prescription...more

Bradley Arant Boult Cummings LLP

Solar Industry Group Releases New Standard for Solar Supply Chain Transparency

The Solar Energy Industries Association (SEIA), a leading solar industry group, recently published a new supply chain traceability standard, Standard 101, for public comment. The standard is intended to provide “a rubric that...more

BakerHostetler

The PROVE IT Act

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The Providing Reliable, Objective, Verifiable Emissions Intensity and Transparency Act, or the PROVE IT Act, is a bipartisan act aimed at enhancing the transparency and accountability of global carbon emissions. Introduced by...more

Thomas Fox - Compliance Evangelist

The Boeing Monitorship: Memo to Attorney General Garland and Kelly Ortberg

Gentlemen - I have written blog posts and articles about the proposed Plea Agreement negotiated between Boeing and the Department of Justice (DOJ). As the leaders of both organizations, I wanted to address you both...more

Cozen O'Connor

Democratic AGs File Amicus Brief Supporting Drug Pricing Transparency Law

Cozen O'Connor on

A group of 21 Democratic AGs filed an amicus brief with the U.S. Court of Appeals for the Ninth Circuit supporting Oregon in its defense of H.B. 4005, which requires pharmaceutical manufacturers to report certain information...more

Thomas Fox - Compliance Evangelist

Boeing: Accept the Omnibus Monitor Approach

I recently wrote a series of blog posts and articles on why the Department of Justice (DOJ) should think big and go big with a completely new approach to the monitorship for Boeing under its agreement to take a guilty plea....more

Bennett Jones LLP

Clarity and Confusion: Updates to Canada's Guidance on Forced Labour Reporting Requirements

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As businesses finalize their reports under the Fighting Against Forced Labour and Child Labour in Supply Chains Act (the Act) in advance of the May 31, 2024, statutory deadline, Public Safety Canada has updated its...more

Morgan Lewis - As Prescribed

California’s Revised Prescription Drug Price Transparency Regulations Effective April 1

Effective April 1, 2024, California will expand its existing prescription drug price transparency requirements by enacting legislation to amend and clarify requirements on wholesale acquisition cost increase reporting and...more

Robinson+Cole Manufacturing Law Blog

Why The Secrecy? U.S. Privately Held Manufacturers Can Benefit From Revealing More Information On Their Websites

Stop me if you have seen this before. You visit the website of a U.S. privately held manufacturer, and you click on the “About Us” page (if one exists) to find only generic information that could describe any manufacturing...more

K&L Gates LLP

Brussels Regulatory Brief: February 2024

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Antitrust and Competition - The European Commission Carried Out Unannounced Inspections in the Tires Sector - On 30 January 2024, the Commission conducted dawn raids at the premises of several companies active in the tires...more

Quarles & Brady LLP

The Lower Costs More Transparency Act of 2023

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The Lower Costs More Transparency Act of 2023, passed by the House 320-71 on Monday, December 11, 2023, would institute new transparency and pricing rules on pharmacy benefit managers (PBMs) and hospitals. The bill would...more

White & Case LLP

Where Things Stand on Drug Pricing at the Halfway Point of 2023

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While only slightly past the midway point of 2023, it has already been a busy year for developments in drug pricing. Notably, CMS released its final guidance in preparation for price negotiations and the first 10 drugs...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

Buchalter

New Patient Disclosure Requirement Effective January 1, 2023

Buchalter on

To increase transparency regarding payments to physicians by drug and medical device companies, Governor Newsom signed AB 1278, which imposes certain additional disclosure obligations on physicians. Beginning on January 1,...more

Gardner Law

Transatlantic Legal-Regulatory Update: Live from the Heart of Silicon Valley

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US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more

Perkins Coie

Sustainability Trends and IP Issues for Fashion Brands

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The fashion industry is one of the most polluting industries in the world and is responsible for roughly 10% of global greenhouse gas emissions. There are many contributing factors to this problem, including pollution from...more

MoFo Life Sciences

Five Key Takeaways From FDA’s Transparency Of AI/Ml-Enabled Medical Devices Virtual Workshop

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On October 14, 2021, the Food and Drug Administration (FDA) held a virtual public workshop on transparency surrounding Artificial Intelligence/Machine Learning (AI/ML) enabled medical devices. The workshop focused on the...more

Mintz - Health Care Viewpoints

Coverage of FDA’s AI/ML Medical Devices Workshop - Part 3: A Summary of the Panel Discussions

In the weeks leading up to FDA’s October 14, 2021 Transparency of AI/ML Enabled Medical Devices Workshop (Workshop), we took a brief look at the history of FDA’s regulation of medical device software and the agency’s more...more

Miles & Stockbridge P.C.

President Biden Signs Executive Order to Strengthen Buy American Act Provisions

On January 25, 2021, President Biden issued an Executive Order on Ensuring the Future Is Made in All of America by All of America’s Workers. The order is part of his “Build Back Better Recovery Plan” to strengthen American...more

Parker Poe Adams & Bernstein LLP

How Much Will President Biden's Buy American Order Change Content Requirements? To Be Determined

Manufacturers are likely to face a tighter definition of American-made products and a stricter process for securing waivers as a result of President Joe Biden’s executive order this week. But the exact details will come from...more

McCarter & English Blog: Government Contracts...

Big Changes To Buy American—Biden Issues Broad Executive Order On The Future Of Domestic Purchasing In Federal Procurement

On January 25, 2021, President Biden issued a sweeping Executive Order titled “Ensuring the Future Is Made in All of America by All of America’s Workers” (Order), which is intended to be the first step toward fulfilling his...more

Holland & Knight LLP

Biden Administration Issues Executive Order on Made in America Laws

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President Joe Biden signed on Jan. 25, 2021, executive order (EO) "Ensuring the Future Is Made in All of America by All of America's Workers," that directs a process for updating domestic preferences. This EO builds upon a...more

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