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Government declines to appeal ruling in PBM accumulator programs MDRP final rule litigation

On Tuesday, May 17, 2022, the U.S. District Court for the District of Columbia issued a decision granting the Pharmaceutical Research and Manufacturers of America’s (PhRMA)’s...

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UK Real Estate Life Sciences: what are the issues facing landlords, developers and investors?
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Over the last eighteen months we have seen more and more landlords, developers and investors looking at opportunities to invest in the UK life sciences sector. As with any new and...

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Senate proposes greater FDA oversight of Lab Developed Tests
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On May 17, the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee published a discussion draft of their FDA user fee program reauthorization package, the “Food and...

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D.C. District Court rules for PhRMA in PBM accumulator programs Final Rule litigation

On Tuesday, May 17, 2022, the U.S. District Court for the District of Columbia issued a decision granting the Pharmaceutical Research and Manufacturers of America’s (PhRMA)’s...

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Restrictions on lawyer ads involving drugs and medical devices are not unconstitutional, says federal court

The Fourth Circuit has found that a West Virginia state law restricting how attorneys can solicit clients in pharmaceutical and medical device cases does not violate the First Amendment. At ...

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FDA updates “cybersecurity in medical devices” guidance, seeks industry input

The U.S. Food and Drug Administration (FDA) issued updated draft guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket...

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MDRP: CMS issues Manufacturer Release on multiple best prices reporting option for VBPs

Last week, the Centers for Medicare & Medicaid Services (CMS) issued Manufacture Release 116, available here, which provides technical guidance to manufacturers on the multiple best...

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FDA finalizes guidance on premarket pathways for combination products

Recently, the U.S. Food and Drug Administration’s (FDA’s) Office of Combination Products (OCP) published the final guidance “Principles of Premarket Pathways for...

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FDA proposes to conform the Quality System Regulation to the ISO 13485 standard

On February 22, the U.S. Food and Drug Administration (FDA) published its long awaited proposed rule entitled, “Medical Devices; Quality System Regulation Amendments,” which...

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