Duane Morris

Duane Morris's articles

  1. Life Sciences

Montana Set to Become a “Wild West” Hub for Experimental Medical Treatments and Therapies – Duane Morris Life Sciences Law

By Vicki G. Norton, Ph.D., and Brandon A. Chan Ph.D. The Federal Food, Drug and Cosmetic Act generally prohibits access to investigational drugs that have not yet been approved by the United States Food and Drug Administration. Patients that have been diagnosed with a life-threatening or seriously debilitating disease may request […]
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  1. Life Sciences

Federal Court Grants EPA Request to Stay Litigation Challenging 2024 Ethylene Oxide Regulation Pending Agency’s Reconsideration

By Sharon L. Caffrey, Jeffrey S. Pollack and Coleen W. Hill In June 2024, industry and environmentalist parties filed a petition in the U.S. Court of Appeals for the District of Columbia Circuit for review of a national emission standards for hazardous air pollutants regulation applicable to commercial sterilization facilities, which was […]
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  1. Life Sciences

First Circuit Embraces More Restrictive View of False Claims Act Kickback Enforcement Provision – Duane Morris Life Sciences Law

By: Daniel R. Walworth, Christopher H. Casey, Frederick R. Ball, Erin M. Duffy and Joseph R. Welsh The United States Court of Appeals for the First Circuit’s opinion in United States v. Regeneron Pharmaceuticals, Inc. has sharpened the circuit split for demonstrating the effect of a kickback on healthcare decisions under the False Claims […]
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  1. Life Sciences

Federal Court Enjoins Enforcement of NIH’S Rate Change Notice Regarding Indirect Costs – Duane Morris Life Sciences Law

By Dan Walworth, Rolando Sanchez, Frederick Ball, Geoffrey Goodale and Sara Smith Since taking office, the Trump Administration has taken steps to reshape the United States’ federal funding infrastructure. One such action relates to the National Institutes of Health’s (“NIH”) rate change, imposing a 15% cap for indirect costs, for new grants and for existing […]
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  1. Life Sciences

What Companies Need to Know About Regulatory and IP Risks – Duane Morris Life Sciences Law

As the medtech AI market surges toward $615 billion by 2034, companies must navigate complex licensing, regulatory, and intellectual property challenges. Understanding these key issues is essential to unlocking the full potential of AI-driven healthcare innovation. The global market value for medical technology utilizing artificial intelligence (AI) is projected to reach […]
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  1. Life Sciences

FDA Releases Draft AI Guidance – A New Era for Biotech, Diagnostics and Regulatory Compliance – Duane Morris Life Sciences Law

The U.S. Food and Drug Administration’s recent release of two draft guidance documents on the use of artificial intelligence in drug development, biologics and medical devices has sparked both excitement and skepticism. As AI increasingly permeates these fields, the regulatory landscape is just beginning to take shape—and these proposed guidelines take […]
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  1. Life Sciences

FDA Issues Draft Guidance Q&A on Developing Potential Cellular and Gene Therapy Products – Duane Morris Life Sciences Law

In November 2024, the U.S. Food and Drug Administration (FDA) issued draft Guidance responding to frequently asked questions about developing cellular and gene therapy (CGT) products. This draft Guidance supplements existing finalized and draft Guidance on CGT products. Read the full Alert on the Duane Morris LLP Website.
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  1. Life Sciences

Federal Circuit Court Affirms Delisting of Patents Claiming Device Components of Drug Product Without Active Ingredient

In Teva Branded Pharm. Prods. R&D, Inc. v. Amneal Pharms. of N.Y., LLC (No. 2024-1936), the Federal Circuit affirmed the District Court of New Jersey’s order to delist from the FDA Orange Book Teva’s five patents claiming just device components of a drug product without reciting any active ingredient. Read the full Alert […]
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  1. Life Sciences

What Spas Need to Know – Duane Morris Life Sciences Law

The global market for intimate wellness products is expected to grow to $81.4 billion by 2028, up from $51.9 billion in 2021, according to recent market research reports. Once taboo, or the topic of hush-hush conversations, intimate wellness brands are increasingly crossing over into mainstream wellness marketing, collaborating with well-known fashion […]
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  1. Life Sciences

FDA’s Final Guidance on Decentralized Clinical Trials Published – Duane Morris Life Sciences Law

On September 18, 2024, the U.S. Food and Drug Administration (FDA) issued final Guidance on recommendations for conducting decentralized clinical trials (DCTs) for drugs, devices or biological products. Instead of using traditional clinical trial sites, DCTs hold some or all trial activities remotely at locations convenient for trial participants by, for example, using […]
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  1. Life Sciences

FDA’s Latest Draft Guidance on Medical Device PCCPs Incorporates FD&C Act Changes – Duane Morris Life Sciences Law

The U.S. Food and Drug Administration (FDA) recently issued draft Guidance informing medical device manufacturers how to structure a predetermined change control plan (PCCP) to describe appropriate, intended future device modifications. The Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research in consultation with the Center for Drug […]
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  1. Life Sciences

House Oversight Committee Gives Pharmacy Benefit Managers Deadline to Correct Congressional Record of Allegedly Fraudulent Statements

On August 28, 2024, the U.S. House Committee on Oversight and Accountability issued letters to executives of three of the nation’s largest pharmacy benefit managers (PBMs), accusing them of providing false testimony before Congress. Each letter outlines the allegedly false statements and the evidence that the statements contradict. They also outline […]
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