FDA Law

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. Further, “there is little utility in comparing the language of the BIS to that of the AKS.”.

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

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.

Manufacturing 52

Manufacturing Specialization Government IT 52

FDA Law

MARCH 5, 2024

According to the court, AstraZeneca’s “desire” or even “expectation” to sell its drugs to the Government at the higher prices it once enjoyed does not create a protected property interest.” The court reasoned that no one is entitled to sell to the Government at prices the Government will not agree to pay.

Government 64

Government IT Manufacturing Illness 64

FDA Law

JUNE 12, 2023

PFI’s frustration and concern around the current regulatory process overseen by state governments was discussed during the Petfood Forum 2023 convention in Kansas City, MO. PFI has noted that it is not feasible to develop and label products for an individual state.

Manufacturing 45

Manufacturing Individual Government Illness 45

GeriPal

JANUARY 11, 2024

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. So less than six months to live.

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