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Manufacturers Risk Mitigation Life Sciences

Arnall Golden Gregory LLP

OIG Issues Favorable Advisory Opinion Involving Financial Risk Mitigation Arrangements for High-Cost Rare Disease Drug

On June 20, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 24-04, a favorable opinion analyzing a refund and discount program designed to alleviate the...more

Arnall Golden Gregory LLP

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

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

Hogan Lovells

IoT in the EU: Lessons from COVID-19, and next steps for liability and regulation

Hogan Lovells on

The IoT sector has exploded over the past few years, and, even taking into account the globally inhibitive effects of COVID-19, this growth shows few long-term signs of abating. The buoyant, fast-paced IoT industry was the...more

McDermott Will & Emery

Proactive Due Diligence Considerations for Life Sciences Dealmakers

In today’s competitive and fast-paced life sciences dealmaking environment, buyers and investors are often unable to spend as much time on due diligence as they might like. Market players are often highly focused on the...more

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