FDA Law Blog

NOVEMBER 6, 2024

By Sara W. Koblitz — The fight between Jazz, Avadel, and FDA over narcolepsy drug sodium oxybate has been a long and arduous one. Starting in 2022 with a patent certification requirement, both Jazz and Avadel have sued FDA over this drug, with Jazz most recently bringing suit challenging FDA’s decision that Avadel’s Lumryz (sodium oxybate) is clinically superior to Jazz’s Xywav (sodium oxybate) in 2023.

Clinic 111

Clinic IT Patient-Centered Consulting 111

The Clinical Problem Solvers

NOVEMBER 6, 2024

[link] Title – Dr.

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FDA Law Blog

NOVEMBER 6, 2024

By Jennifer D. Newberger — Though digital health is not new, it can still often be difficult to determine with precision the regulatory requirements applicable to a particular software product. Sometimes this is because FDA has not opined on a specific set of facts, but more often it is because FDA seems to take different approaches to the same technology offered by different companies.

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NPR Health

NOVEMBER 6, 2024

Trump's victory gives a broader platform to critics of federal health programs. Among other moves, he may try to weaken the Affordable Care Act and cut funding for Medicaid coverage.

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