FDA Law Blog

AUGUST 4, 2022

In September 2020, the Agency issued an unfavorable advisory opinion to Pfizer, concluding that the proposal was “highly suspect” under the AKS “because one purpose of the [proposed program]—perhaps the primary purpose—would be to induce Medicare beneficiaries to purchase [Pfizer’s] federally reimbursable Medications.”

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FDA Law Blog

OCTOBER 25, 2021

The Medical Device Amendments of 1976 created the initial premarket application (PMA) review and 510(k) substantial equivalence review processes. Only a year later, in 1977, FDA promulgated regulations governing 510(k) reviews (21 C.F.R. The regulatory uncertainty has ill?befitted Part 807, Subpart E). Part 860.

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The Clinical Problem Solvers

AUGUST 25, 2020

Trainees may use this foundation to question how this might impact their medical education and think about this educational legacy may be reformed through curricular and structural changes at their institutions. Jefferson & Hedwig Lee (2020) Illness spillovers of lethal police violence: the significance of gendered marginalization.

Community 52

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GeriPal

MAY 12, 2022

Raj: It was indeed very, very gradual, and the seeds were sown when I was a medical student. 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.

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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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