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Environmental Protection Agency (EPA) Pharmaceutical Industry

Alston & Bird

Feds Continue to Reform Approach to Regulation of Biotech Products

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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

Troutman Pepper

2024 Mid-Year Review: State AGs Shaping Regulatory Landscapes

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In 2024, the landscape of state attorneys general (AGs) is poised for significant change, with numerous elections and regulatory actions reshaping priorities and enforcement strategies. This dynamic environment reflects the...more

Epstein Becker & Green

Another Leak Confirmed and Other Important Decisions and Divisions Issued, but Not Loper or Trump - SCOTUS Today

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The Supreme Court’s day started with the specter of yet another leak of a reproductive rights decision having occurred....more

Dechert LLP

Dechert Re:Torts - Issue 15

Dechert LLP on

Previous editions of Re:Torts (It’s (Still) Important Enough to Get It Right; Opioid Public Nuisance Question) have covered decisions that addressed whether various states permit public nuisance claims in connection with the...more

Mitchell, Williams, Selig, Gates & Woodyard,...

National Capacity Variance/Generator Status: U.S. Environmental Protection Agency Guidance Addresses Hazardous Waste...

The United States Environmental Protection Agency (“EPA”) addressed in a March 22nd letter questions it was asked regarding the application of the Resource Conservation and Recovery Act (“RCRA”) to pharmaceutical hazardous...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?

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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

Mitchell, Williams, Selig, Gates & Woodyard,...

Technical Corrections / Hazardous Waste Generator Improvements / Pharmaceuticals / Definition of Solid Waste: U.S. Environmental...

The United States Environmental Protection Agency (“EPA”) issued a direct final rule on August 9th denominated: Hazardous Waste Generator Improvements Rule, the Hazardous Waste Pharmaceuticals Rule, and the Definition of...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

Benesch

Trade Secrets/Non-Compete Quarterly Update - Q2 2023

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Welcome to our Q2 Trade Secret and Restrictive Covenant Update. As you can tell from the update, Q2 was a busy quarter in this space from both a regulatory, legislative, civil litigation and criminal litigation perspective....more

Rivkin Radler LLP

Insurance Update - January 2022

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Cases discussed in our January Insurance Update answer these questions: •A commercial crime policy covers property that the insured “holds for others.” In the context of a phishing scheme, does “hold” mean the insured...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 6. In This Month’s E-News: June 2021

Report on Research Compliance 18, no. 6 (June 2021) - Clemson University is pushing back against recommendations by auditors for the National Science Foundation Office of Inspector General (OIG) that it repay $276,440,...more

Beveridge & Diamond PC

Washington State Provides Hazardous Waste Updates for Business

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On September 30, 2020, the Washington State Department of Ecology (Ecology) adopted updates to its Dangerous Waste Regulations, Chapter 173-303 WAC. These updates go into effect on October 31, 2020. The updated...more

Sheppard Mullin Richter & Hampton LLP

President Trump’s Executive Order Mandating the Purchase of U.S. Drugs Evokes Criticism

On Thursday, August 6, 2020 President Trump signed an Executive Order, mandating that certain drugs and medical supplies purchased by federal agencies, including the Department of Health and Human Services, Department of...more

Snell & Wilmer

President Trump Issues Executive Order to “Buy American” with Respect to “Essential Medicines”

Snell & Wilmer on

Amidst a flurry of policymaking from the White House last week, President Trump issued the Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States on August...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

Arnall Golden Gregory LLP

Hazardous Waste Pharmaceuticals Management Standard Effective in Georgia, Other States

While health care providers, including long-term care providers, rightly have been consumed the past several months with preparing for and responding to the novel coronavirus pandemic, regulatory agencies across the United...more

Bass, Berry & Sims PLC

DOJ Announces 2019 FCA Recovery, Majority Came from Healthcare Industry

The Department of Justice (DOJ) announced this month that it obtained over $3 billion in settlements and judgments from civil fraud and false claims cases during the fiscal year ending September 30, 2019 (FY 2019). Of this...more

Searcy Denney Scarola Barnhart & Shipley

Injured Patients Want Consolidation of Zantac Lawsuits

Litigation Update - On January 30, 2020, class action, consumer protection and pharmaceutical lawyers from around the country will be in federal court in Tampa, Florida to argue before a panel of federal judges whether...more

Mitchell, Williams, Selig, Gates & Woodyard,...

Manifesting Non-Creditable Hazardous Waste Pharmaceuticals/New Four Character Code: U.S. Environmental Protection Agency RCRA...

The United States Environmental Agency (“EPA”) released December 19, 2019 interpretive guidance titled: Manifesting Non-Creditable Hazardous Waste Pharmaceuticals – New Four Character Code (“Guidance”) - The document...more

Polsinelli

DOJ’s False Claims Act Recoveries Rise to More Than $3 Billion in FY2019, With Continued Emphasis on Health Care Fraud Cases

Polsinelli on

On January 9, 2020, the Civil Division of the U.S. Department of Justice (DOJ) announced that it recovered over $3 billion from civil False Claims Act (FCA) judgments and settlements in the fiscal year ending September 30,...more

Arnall Golden Gregory LLP

USP 800 to Present Significant Compliance Challenges for Long-Term Care Providers

When many long-term care providers first hear about USP General Chapter <800> Hazardous Drugs--Handling in Healthcare Settings (“USP 800”), they naturally confuse it with the final EPA hazardous pharmaceuticals rule (“EPA...more

Clark Hill PLC

Window On Washington - Vol. 3, Issue 42

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Outlook for This Week in the Nation’s Capital - Thank you to all who have served. Happy Veterans Day from Clark Hill....more

Bergeson & Campbell, P.C.

FDA Announces Availability Of Draft Guidance On Bioequivalency For Soluble Powder Oral Dosage Form Products And Type A Medicated...

The U.S. Food and Drug Administration (FDA), on September 30, 2019, announced the availability of a draft guidance for industry (GFI) #171 titled “Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and...more

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