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

FDA Law

Mr. Bawduniak alleged that, between 2009 and 2014, Biogen paid illegal kickbacks to its largest prescribers to induce them to prescribe the company’s multiple sclerosis drugs, Avonex, Tysabri and Tecfidera, and discourage them from prescribing newer competitor products. This lawsuit was brought to the U.S. See United States ex rel.

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15 Years Strong: Rare Disease Week’s Remarkable Journey of Support

FDA Law

Sasinowski — In 2009 — 15 years ago — the National Organization for Rare Disorders (NORD) announced the first U.S. In 2009 I served as Chair of NORD and through the hard work of countless colleagues we inaugurated the first Rare Disease Day. By Frank J. recognition of Rare Disease Day.

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From GRP to SIUU – the Evolution of FDA Guidance on Off-Label Dissemination of Scientific Information

FDA Law

Previous iterations of this guidance from 2009 and 2014 (blogged on here and here ) were known as Good Reprint Practices (GRP). However, there’s a clear shift in FDA’s approach that is noticeable from the title of the Draft Guidance, alone.

Clinic 64
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Episode 148: Antiracism in Medicine Series Episode 4 – Dismantling Race-Based Medicine Part 2: Clinical Perspectives

The Clinical Problem Solvers

Tsai has seen race-based medicine play out in clinical practice 10:45 What role should race play in making clinical decisions? 13:16 Status of the current conversation on removing race from eGFR calculators: why is it so contentious? Poet Marge Piercy has written, “The work of the world is as common as mud.”

Clinic 52
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I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 1)

FDA Law

However, more recently, we have observed that DEA special agents are also becoming more involved in investigations of registrants, thus, raising the stakes for compliance. Thus, non-compliance can be very costly, so it is more important than ever to dot every “i,” cross every “t.”. DEA can seek administrative action, and working with U.S.

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I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 1)

FDA Law

However, more recently, we have observed that DEA special agents are also becoming more involved in investigations of registrants, thus, raising the stakes for compliance. Thus, non-compliance can be very costly, so it is more important than ever to dot every “i,” cross every “t.”. DEA can seek administrative action, and working with U.S.

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Is Hospice Losing Its Way: A Podcast with Ira Byock and Joseph Shega

GeriPal

For others, this piece, while painful to read, gave voice to what they have been feeling over the last decade – hospice has in some ways lost its way in a quest of promoting profit over care. If you are interested in signing the position statement “Core Roles and Responsibilities of Physicians in Hospice Care”, click here. Is it you, Ira?

IT 113