FDA Law

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.”

Manufacturing 98

Manufacturing Medical Government IT 98

FDA Law

SEPTEMBER 22, 2022

While the authors did a yeoman’s job of combing through the criminal cases to identify what they view as a “handful” of cases and call for increased use of the Park doctrine, we at the FDA Law Blog respectfully disagree. The JAMA editorial notes that there are few Park cases for two primary reasons: [The government] may lead.

Private Practice 59

Private Practice Government Individual Specialization 59

FDA Law

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.

Manufacturing 52

Manufacturing Specialization Government IT 52

GeriPal

JANUARY 11, 2024

Summary Transcript Summary Four percent of deaths in Canada are due to Medical Assistance in Dying (MAID). 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. Four percent. This is Eric Widera.

Illness 144

Illness IT Medical Provider 144

FDA Law

JUNE 4, 2025

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.

Chronic Disease 59

Chronic Disease Government Chronic Condition Clinic 59

GeriPal

MARCH 16, 2023

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. But I was focused on his very ill wife. I was like, I’m fascinated when I read medical books and they’re quoting patients these long paragraphs. Eric: Yeah.

IT 105

IT Healthcare Professional Healthcare Transportation 105

FDA Law

APRIL 21, 2021

When this author read the January Notice, it seemed like an ill-thought-out proposal. The government appeared to agree on the methodology point, stating that “adverse event data is not adequate on its own for assessing safety, let alone whether to determine a device to be exempt from 510(k).”.

Manufacturing 40

Manufacturing Government IT Consulting 40