AI-Powered Medtech: What Companies Need to Know About Regulatory and IP Risks
Duane Morris Life Sciences Law
by Duane Morris
2d ago
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 about $615 billion by ..read more
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FDA Releases Draft AI Guidance – A New Era for Biotech, Diagnostics and Regulatory Compliance
Duane Morris Life Sciences Law
by Duane Morris
3d ago
The U.S. Food and Drug Administration’s recent release of two draft guidance documents on the use of artificial intelligence in drug development, biologics and medical devices has sparked both excitement and skepticism.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 a step in that ..read more
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FDA Issues Draft Guidance Q&A on Developing Potential Cellular and Gene Therapy Products
Duane Morris Life Sciences Law
by Duane Morris
2w ago
In November 2024, the U.S. Food and Drug Administration (FDA) issued draft Guidance responding to frequently asked questions about developing cellular and gene therapy (CGT) products. This draft Guidance supplements existing finalized and draft Guidance on CGT products.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 ..read more
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Federal Circuit Court Affirms Delisting of Patents Claiming Device Components of Drug Product Without Active Ingredient
Duane Morris Life Sciences Law
by Duane Morris
3w ago
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 on the Duane Morris ..read more
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Promoting Intimate Health and Wellness Products and Treatments: What Spas Need to Know
Duane Morris Life Sciences Law
by Duane Morris
3M ago
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 and beauty brands and ..read more
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FDA’s Final Guidance on Decentralized Clinical Trials Published
Duane Morris Life Sciences Law
by Duane Morris
4M ago
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 telehealth appointments, outsourcing visits ..read more
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FDA’s Latest Draft Guidance on Medical Device PCCPs Incorporates FD&C Act Changes
Duane Morris Life Sciences Law
by Duane Morris
5M ago
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 Evaluation and Research and ..read more
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Artificial Intelligence in Medtech
Duane Morris Life Sciences Law
by Duane Morris
6M ago
Given the vast amounts of data available, including raw measurements, diagnostic information, treatment plans, and regulatory guidelines, the biomedical technologies sector stands to gain immensely from artificial intelligence (AI), particularly machine learning (ML). ML, at its core, learns from training datasets to identify patterns, which can then be applied to new input data to make ..read more
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Induced Infringement Suit Against Generic Pharma Revived Despite Skinny Label Compliance
Duane Morris Life Sciences Law
by Duane Morris
7M ago
In Amarin Pharma v. Hikma Pharmaceuticals USA (No. 2023-1169), the Federal Circuit recently reversed the District Court of Delaware’s ruling and held that Amarin’s complaint plausibly pleads that Hikma actively induced healthcare providers’ direct infringement, while also indicating that it “may agree with the district court (and Hikma)” that Hikma’s skinny label alone did not, as a ..read more
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Federal Trade Commission Poised to File Suit Against Pharmacy Benefit Managers Based on Unlawful Medication Pricing
Duane Morris Life Sciences Law
by Duane Morris
7M ago
On July 10, 2024, multiple media sources reported that the Federal Trade Commission intends to file suit against the nation’s three largest pharmacy benefit managers over​ allegations of improper pricing in connection with their negotiations with drug manufacturers that dramatically increased prices for consumers and lined the PBMs’ pockets with lucrative “rebates.” Tp read the ..read more
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