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

FDA Law Blog

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 Blog

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 Blog

Previous iterations of this guidance from 2009 and 2014 (blogged on here and here ) were known as Good Reprint Practices (GRP). The presentation should be accompanied by the reprint and the reprint, itself, must meet the criteria articulated in the SIUU Guidance for reprints.

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

FDA Law Blog

Recent Department of Justice (“DOJ”) press releases continue to show evidence of reported registrant civil settlements with the Government alleging recordkeeping and reporting deficiencies. Incomplete and inaccurate records currently subject registrants to civil monetary penalties of up to $15,691 per violation.

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

FDA Law Blog

Recent Department of Justice (“DOJ”) press releases continue to show evidence of reported registrant civil settlements with the Government alleging recordkeeping and reporting deficiencies. Incomplete and inaccurate records currently subject registrants to civil monetary penalties of up to $15,691 per violation.

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Agitation Podcast Series Episode 2: Non-pharmacologic management of agitated children

PEMBlog

Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. Government. 2009 Nov;27(4):655-67, ix. 2009 Jun;21(3):196-202. These articles will take another look at the content included in this episode. Coburn VA, Mycyk MB. Physical and chemical restraints. Emerg Med Clin North Am.

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

GeriPal

It’s going to be published as a special report in JPM I hope in May with as of today, 279, I think HPM physician colleagues, signatures including 21 of the living past presidents of the academy. As somebody who has been part of literally more non-profits than I can remember, non-profit governance structures is a pain in the ass.

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