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Top 10 Takeaways From FDA's Revised Quality System Requirements For Medical Devices - Life Sciences, Biotechnology & Nanotechnology

On February 2, 2024, the U.S. Food and Drug Administration ("FDA") published a final rule1 to amend the current good manufacturing practice requirements. ....

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First Circuit Affirms Convictions Of Former Acclarent Executives Related To Off-Label Promotion Of Medical Device - Life Sciences, Biotechnology & Nanotechnology

On December 14, 2023, the U.S. Court of Appeals for the First Circuit issued a long-awaited opinion affirming the convictions of William Facteau and Patrick Fabian. ....

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Try, Try Again: FDA Issues Draft Guidance On Communication Of Scientific Information On Unapproved Uses Of Medical Products - Food and Drugs Law

On October 23, 2023, the Food and Drug Administration ("FDA") released a draft guidance for industry entitled "Communications From Firms to Health Care Providers Regarding. ....

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New SEC Private Fund Rules: Special Considerations For Real Estate Fund Advisers - Fund Management/ REITs

As discussed in the recent Ropes & Gray Alert "SEC Adopts New Private Fund Adviser Rules", the SEC adopted new private fund reforms on August 23, 2023. ....

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Massachusetts Court Validates Broker-Dealer Fiduciary Duty Rule, Increasing Threat Of Patchwork Standards Of Care

In its August 25, 2023 decision in Robinhood Financial LLC vs. Galvin, the Massachusetts Supreme Judicial Court reversed a trial court s decision and validated a 2020 Massachusetts state regulation. ....

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