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Second Circuit Agrees that Copay Assistance Programs May Violate the Anti-Kickback Statute

FDA Law

That court granted summary judgment to the government on the APA claim and rejected Pfizer’s narrower reading of the AKS, which would require an element of “corrupt” intent to impose AKS liability. Pfizer emphasized to OIG that it would not offer this copay assistance as part of any advertisement or solicitation for tafamidis.

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FDA Publishes De Novo Classification Final Rule with Few Changes from the Proposed Rule

FDA Law

Only a year later, in 1977, FDA promulgated regulations governing 510(k) reviews (21 C.F.R. Yet, all this time, this process lacked implementing regulations governing the process and the criteria for approval. The regulatory uncertainty has ill?befitted Part 807, Subpart E). The new rule will be codified in 21 C.F.R.

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What is going on with MAID in Canada? Bill Gardner, Leonie Herx, & Sonu Gaind

GeriPal

To be eligible in Canada patients must have a “ grievous and irremediable ” condition, including disability ; they do not have to have a terminal illness with a prognosis of less than 6 months. A planned expansion of MAID to include people with mental illness was placed on hold until March 2024. Bill, welcome back to GeriPal.

Illness 144
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The MAHA Assessment’s Implications: Drugs (Part One)

FDA Law

Ordinarily, a public health initiative of such magnitude would have been governed by a transparent multi-step process featuring public meetings and drawing on external scientific expertise. In other words, as you read this, the Assessments findings and recommendations are getting baked into federal government policy, for better or worse.

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Writing for the Lay Public: Rosanne Leipzig and Louise Aronson

GeriPal

And then I feel like when I’m in clinic I’m helping individuals, and you only have so much time to help so many people. In clinic, I’m helping what, hundreds or thousands. Louise: Well again, if you take that approach, you also get rid of ableism and ageism against children and prejudice against people who are ill.

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