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

FDA Law Blog

district court of Massachusetts by former employee and whistleblower Michael Bawduniak in April 2012 as a qui tam action. Department of Health and Human Services (HHS) and the Department of Justice (DOJ) have aggressively pursued antikickback cases in the healthcare industry. This lawsuit was brought to the U.S. Bawduniak v.

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Goodbye NSURE, Hello ACNU! FDA Issues Long-Awaited Proposed Rule to Bring OTC Drugs with a Little Something Extra to Market

FDA Law Blog

In March 2012 , FDA convened a public meeting to discuss a new paradigm under consideration, “Using Innovative Technologies and Other Conditions of Safe Use to Expand Which Products Can Be Considered Nonprescription”. Among other things, the applicant would need to include a statement of the necessity of the ACNU.

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Gabapentinoids – Gabapentin and Pregabalin: Tasce Bongiovanni, Donovan Maust and Nisha Iyer

GeriPal

By 2015 that number increased to 4% of US adults. There are a lot of reasons that may explain the massive increase in use of these drugs. One thing is clear, it is not because people are using it for FDA approved indications. The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia.

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RCT of Default Inpatient PC Consults: Kate Courtright & Scott Halpern

GeriPal

First, in our editorial, we expressed concern about the length of stay metric not being patient centric, though important for health systems focused on cost savings. It was refreshing to hear Scott and Kate express similar sentiments. Much more to come. And I get to play Phish, who Scott has seen about 100 times in concert. I saw them only twice.

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End-of-Life Doulas: A Podcast with Jane Euler, Beth Klint, and John Loughnane

GeriPal

There’s an organization that I took my training from, which began, I want to say, in 2012. But before we jump into that topic, John, do you have the song request for Alex? John: I do. It’s Jimmy Buffett’s song, Bubbles Up. It was on his last album. As you may know, Jimmy Buffett passed away in August of a rare skin cancer.

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Hastening Death by Stopping Eating and Drinking: Hope Wechkin, Thaddeus Pope, & Josh Briscoe

GeriPal

And she was from Oregon, of course, and in Oregon in 2012, she had completed an advanced directive for stopping eating and drinking once she had advanced dementia. Eric 00:13 And Alex, who do you have with us today? Alex 00:14 We have a very full house today. Hope Wechkin brought this topic to us. Thank you, Hope, for bringing a topic to us.

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Optimizing Nutrition in Aging: A Podcast with Anna Pleet, Elizabeth Eckstrom, and Emily Johnston

GeriPal

Summary Transcript Summary What is a healthy diet and how much does it really matter that we try to eat one as we age? That’s the topic of this week’s podcast with three amazing guests: Anna Pleet, Elizabeth Eckstrom, and Emily Johnston. Emily Johnston is a registered dietitian, nutrition researcher, and Assistant professor at NYU.

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