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Rivkin Radler LLP

Seventh Circuit Rejects Extension of AKS to Marketing Companies Without Evidence of Intent to Induce Referrals

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The U.S. Court of Appeals for the Seventh Circuit recently rejected an effort by the federal government to extend the federal Anti-Kickback Statute (AKS) to a marketing company in the absence of influence by the company over...more

Morgan Lewis

Seventh Circuit Overturns AKS Conviction in DME Marketing Case

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The US Court of Appeals for the Seventh Circuit recently issued a decision that has important implications for stakeholders in the durable medical equipment (DME), medical device, and telehealth space as well as future civil...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

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As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q4 2023 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Arnall Golden Gregory LLP

FDA Tries to Keep Up: FDA Publishes Two New Items Related to Artificial Intelligence

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FDA has recently published two much-anticipated items related to artificial intelligence (“AI”), one pertaining to medical devices and the other to drug manufacturing. FDA has cleared or approved hundreds of products that...more

MoFo Life Sciences

FDA Clarifies The Human Factors Or Usability Information To Include In A Device Marketing Submission

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If you are a device manufacturer, what human factors and usability information should you include in your marketing submission? What if your device has the same user interface as an existing device?...more

Patterson Belknap Webb & Tyler LLP

In False Ad Dispute Between Inhaler Companies, Court Grants PI Enjoining Unsupportable Clinical Superiority Claims

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In its recent decision granting a preliminary injunction in GlaxoSmithKline v. Boehringer Ingelheim Pharmaceuticals, No. 19-5321, the United States District Court for the Eastern District of Pennsylvania enjoined a...more

Smart & Biggar

Canada cracks down on COVID-19 related product advertising claims

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COVID-19 has resulted in the launch of numerous new products, as well as numerous new claims about existing products. Products can be classified as drugs (including natural health products and hard surface disinfectants) or...more

Butler Snow LLP

Express Preemption of Consumer Protection Actions: Preventing a Patchwork of State Drug and Device Regulations

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The Supremacy Clause of the United States Constitution declares federal law to be the “supreme Law of the Land.” Thus, when federal law and state law conflict, the state law is “preempted,” or rendered without effect. Under...more

Hogan Lovells

Poland: impact of a no-deal Brexit scenario on biocidal products’ data changes, and the validity of parallel import licences for...

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The President of the Polish Office for the Registration of Medicinal Products, Medical Devices, and Biocidal Products issued two more Brexit related communiques....more

Snell & Wilmer

FDA Draft Guidance Aims to Clarify Appropriate Character-Space-Limited Social Media Use by Drug and Device Firms: Part One of Two

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As technology continues to evolve, so do the ways in which patients and healthcare providers obtain information pertaining to medical products regulated by the Food and Drug Administration (FDA). Thomas Abrams, Director of...more

Morgan Lewis

Medical Device Update: FDA Medical Device Guidances Issued in 2014’s Second Quarter

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In recent months, the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has issued draft and final guidance documents at a relatively fast pace. To assist interested parties, we have...more

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