FDA Law Blog

AUGUST 4, 2022

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 appealed to the Second Circuit.

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FDA Law Blog

OCTOBER 25, 2021

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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The Clinical Problem Solvers

AUGUST 25, 2020

Pearls Defining Structural Racism Structural racism is a term that acknowledges that racism is perpetuated beyond individual interactions and interpersonal racism, but is present in the systems and policies that govern our everyday lives. N Engl J Med. 2016;375(22):2113-2115. doi:10.1056/NEJMp1609535 Alyasah Ali Sewell, Justin M.

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GeriPal

MAY 12, 2022

So, we formed this organization called Pain and Palliative Care Society in the Northern Kerala city of Kalakkad based in the government medical college. But when I retired from government service, I left Kalakkad in 2002. Raj: We are not limited by definitions because we started our first non non-government organization.

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Common Sense Family Doctor

FEBRUARY 21, 2025

Oh, and the CDC's National Immunization Survey has been canceled by the so-called Department of Government Efficiency, even if the Epidemic Intelligence Service seems to have received a temporary reprieve.) This real-life scenario is probably Dr. Adam Ratner's worst nightmare, but it couldn't have come at a better time for his book.

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Common Sense Family Doctor

MARCH 23, 2025

This post first appeared on March 6, 2018, during the first Trump administration's failed attempt to eliminate the Agency for Healthcare Research and Quality (AHRQ). Now the Department of Government Efficiency is trying again, threatening 90% staff reductions that would decimate the agency. Update: the NGC ceased operating in 2018.]

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