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Permanente Live webinar — Finding success in value-based care

Permanente Medicine

This complimentary virtual event will feature a candid, strategic conversation with national health care leaders as they share their insights and best practices from proven value-based care models to help health systems, physician groups, and health plans navigate this critical transformation.

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Biogen agrees to pay $900 million in largest FCA Settlement Ever Secured without Government’s Intervention

FDA Law

For example, the government closely scrutinizes speaker programs or trainings that involve lavish venues or meals and free alcohol, invite attendees with no legitimate business reason to attend, and present little substantive information to them.

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Green Practice News: April 2025

My Green Doctor

According to the 2023 report of the Lancet Countdown, mortality caused by extreme heat events increased by 53.7% Behavior Change Happens in the Exam Room Unlike government agencies or corporations, healthcare professionals speak directly to individuals in a trusted, one-on-one setting. Need help planning an event? of total U.S.

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PhRMA Code Revised in Response to OIG Special Fraud Alert on Speaker Programs

FDA Law

The PhRMA Code is updated periodically to reflect changes in industry norms or, as is likely the case with the latest revision, in response to political pressure or increased scrutiny from the federal government. If held in a third-party venue, the venue “should not be extravagant or the main attraction of the event” (e.g.,

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No Sleep ‘Til District Court: Jazz Sues FDA Over Sodium Oxybate Clinical Superiority Determination

FDA Law

More specific to the facts of this case than the governing statute, Jazz argues that OOPD’s determination that Lumryz is clinically superior to Xywav is inconsistent with FDA’s regulations.

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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway

FDA Law

Lastly, the reforms enacted by FDORA required that FDA publish guidance on early consultation with FDA to identify novel surrogate or intermediate clinical endpoints, use of novel trials designs for postapproval studies, the expedited withdrawal procedures, and considerations related to the use of surrogate and intermediate clinical endpoints.

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Demystifying the Role of HHS and ASPE in Guiding Federal Aging Policy and Priorities with Dr. Tisamarie Sherry

GeriPal

For the policy buffs and policy newbies out there, we hope this podcast is an essential primer to government in action. We talk about: . The structure of federal agencies and how they coordinate. Priorities of the National Alzheimer’s Project Act, and the unique role of ASPE and BHDAP in guiding the agenda and long-term goals.