News & Analysis as of

Environmental Protection Agency (EPA) Medical Devices

Faegre Drinker Biddle & Reath LLP

Biopharma & Medical Device Briefing: PFAS Reporting Requirements; ECHA Substances of Very High Concern List; and MicroRNA...

With the rapidly evolving regulatory landscape, staying on top of the latest updates is crucial for companies in biopharma and medical devices. In this briefing, we highlight recent regulatory and legislative developments...more

Bergeson & Campbell, P.C.

EPA Proposes Updates to Recommendations of Specifications, Standards, and Ecolabels for Federal Purchasing

On September 13, 2024, the U.S. Environmental Protection Agency (EPA) began a public comment period on a proposed update to its Recommendations of Specifications, Standards, and Ecolabels for Federal Purchasing...more

DLA Piper

EPA Expands Mandatory Federal Purchasing Program

DLA Piper on

The US Environmental Protection Agency (EPA) recently announced that it is expanding its Recommendations of Specifications, Standards, and Ecolabels for Federal Purchasing Program (Recommendations Program) to include new...more

Alston & Bird

Feds Continue to Reform Approach to Regulation of Biotech Products

Alston & Bird on

Our Food & Beverage and FDA teams explore a plan from a trio of federal agencies that seeks to implement regulatory reform and update the Coordinated Framework for the Regulation of Biotechnology....more

Pierce Atwood LLP

PFAS in Maine: Legislature Amends the PFAS in Products Law

Pierce Atwood LLP on

On April 16, 2024, Maine Governor Janet Mills signed into law significant amendments to the PFAS in Products Law. Initially passed in 2021, the PFAS in Products Law required manufacturers of products with intentionally added...more

Knobbe Martens

New Ethylene Oxide Regulations may Raise Cost of Sterilization

Knobbe Martens on

Last week, the Environmental Protection Agency (EPA) announced new regulations to reduce ethylene oxide emissions. According to the EPA’s press release, the new regulations are “the strongest measures in U.S. history to...more

Goldberg Segalla

Will Industry Push Back Proactively on Potential PFAS-Use Restrictions?

Goldberg Segalla on

Over the past seven years, our blog has reported extensively on PFAS developments, litigation, and regulations — most of which has focused on the attention surrounding potential risks associated with PFAS, and the scrutiny...more

Faegre Drinker Biddle & Reath LLP

5 Major Drug and Medical Device Developments in 2023

A popular New Year’s trend is to say “goodbye” to all the things that didn’t serve you in 2023, as you usher in new intentions and habits for 2024. Although there were many great trial outcomes and continuing scientific wins...more

Dechert LLP

Dechert Re:Torts - Key Developments in Product Liability and Mass Torts - Issue 10

Dechert LLP on

Senators Focus Attention on Litigation Funding’s Opacity - Building on the momentum we previously noted related to litigation funding, on September 14, Senator John Kennedy introduced the Protecting Our Courts from Foreign...more

Goldberg Segalla

Lawsuits Claim EPA’s EtO Rules are Too Little, Too Late

Goldberg Segalla on

Following the U.S. Environmental Protection Agency’s 2016 finding that ethylene oxide (EtO), a highly effective chemical routinely used to sterilize medical devices and equipment, was significantly more hazardous than...more

Dechert LLP

Dechert Re:Torts - Issue 9

Dechert LLP on

Delaware Supreme Court Rejects No-Injury Medical Monitoring Claims - As part of our ongoing coverage of issues in Medical Monitoring, we noted that the Delaware Supreme Court received a certified question from the U.S....more

Goldberg Segalla

FDA to EPA: Pump the Brakes on New EtO Rules During Supply Chain Shortage

Goldberg Segalla on

With COVID diagnoses spiking across the United States this summer, we cannot yet claim that the pandemic is behind us. In fact, we are still experiencing residual medical device and equipment shortages, which has caused...more

Dechert LLP

Dechert Re:Torts Newsletter - Key Developments in Product Liability and Mass Torts - Issue 2

Dechert LLP on

Federal Appeals Court Dismisses Challenge to Interim PFAS Guidance, Leaving Important Questions Unresolved - A federal appeals court dismissed a challenge to EPA's interim guidance for PFAS levels in drinking water,...more

Goldberg Segalla

EPA Renews Push for New ‘EtO’ Regulations and Outreach

Goldberg Segalla on

Following a study of 100 commercial sterilizer facilities, the U.S. Environmental Protection Agency announced on August 3 it would takes steps to inform communities throughout the country about the risks posed by ethylene...more

Rivkin Radler LLP

Insurance Update - April 2021

Rivkin Radler LLP on

In this month’s update, state high courts consider reimbursement of defense costs, reimbursement of medical marijuana costs, and reimbursement of ransomware payments. Federal courts determine whether a debt collector is...more

Hogan Lovells

Buy American EO applies domestic preferences for "essential medicines" and "medical countermeasures"

Hogan Lovells on

On August 6, 2020, U.S. President Donald Trump issued his much-anticipated "Buy American" Executive Order (EO), intended to increase and support domestic manufacture and Federal government procurement of "essential...more

Pillsbury Winthrop Shaw Pittman LLP

The Regulation of Medical Waste During COVID-19

The rapid spread of the coronavirus has generated new interest in the regulation of medical waste. The COVID-19 crisis is generating a significant amount of regulated medical waste....more

Mintz - Health Care Viewpoints

FCC Simplifies Evaluations of Certain Wireless Medical Devices

The Federal Communications Commission (FCC) regulates wireless medical devices in conjunction with the Food and Drug Administration (FDA), with the FCC’s role related to certain technical concerns such as the successful...more

Akin Gump Strauss Hauer & Feld LLP

What’s New in Washington: 10 Things You Need to Know

As the Trump presidency completes its first 10 weeks, the administration is celebrating big wins on the regulatory reform front while nursing some wounds from a major defeat on efforts to repeal and replace the Affordable...more

Baker Donelson

Washington, D.C. Update – December 2016

Baker Donelson on

With the last-minute passage of a Continuing Resolution (CR) to stave off a government shutdown, the 114th Congress has come to an end. When Congress returns in January, it will be faced with a number of immediate challenges,...more

Bergeson & Campbell, P.C.

Wrap-Up of Federal and State Chemical Regulatory Developments, October 2015

On October 15, 2015, Bergeson & Campbell, P.C. (B&C®) and the Woodrow Wilson International Center for Scholars (Wilson Center) issued a report, "The DNA of the U.S. Regulatory System: Are We Getting It Right For Synthetic...more

Bergeson & Campbell, P.C.

Wrap-Up of Federal and State Chemical Regulatory Developments, September 2015

EPA Releases TSCA Assessment Documents For Flame Retardant Chemicals: On August 18, 2014, the U.S. Environmental Protection Agency (EPA) released for public comment three Problem Formulation and Initial Assessment documents...more

Mintz - Consumer Product Safety Viewpoints

Does CPSC or FDA Have Jurisdiction Over Your Consumer Product?

As our readers know, we write about legal developments that affect companies involved in manufacturing, importing, distributing, and/or selling “consumer products.” In many cases, these products fall squarely within the...more

Bergeson & Campbell, P.C.

Wrap-Up of Federal and State Chemical Regulatory Developments, February, 2015

EPA OEI Office Announces Transfer Of TRI Program To OPPT: On January 22, 2015, U.S. Environmental Protection Agency (EPA) Office of Environmental Information (OEI) announced that EPA has begun the process of transferring the...more

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