FDA Law

AUGUST 4, 2022

Pfizer manufactures tafamidis, a breakthrough treatment for a rare, progressive heart condition known as transthyretin amyloid cardiomyopathy. 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.

Manufacturing 98

Manufacturing Medical Government IT 98

My Green Doctor

MAY 3, 2025

For instance, the UK government’s initiative to install solar panels on National Health Service sites is projected to save each site up to £45,000 annually, amounting to approximately £13 million in total savings per year. The product manufacturers and vendors will need to be active partners as well.

Healthcare 52

Healthcare Healthcare Professional Consulting Management 52

FDA Law

MARCH 5, 2024

First, AstraZeneca alleged that CMS improperly defined a “qualifying single source drug” to include all dosage forms and strengths of the drug marketed by the manufacturer with the same active moiety or ingredient—even if those different forms and strengths were approved under different NDAs. Opinion at 17.

Government 64

Government IT Manufacturing Illness 64

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). FDCA § 513(f)(5). 515(d)(2)(C).

Manufacturing 52

Manufacturing Specialization Government IT 52

FDA Law

JUNE 12, 2023

As anyone familiar with pet (and other animal) food regulation knows, many states require premarket label review and approval and registration of the manufacturer/distributor and/or product for a fee. They have inspectors in the field everyday with eyes on the products, on the local manufactures, and on the distributors and retailers.

Manufacturing 45

Manufacturing Individual Government Illness 45

The Health Policy Exchange

MAY 20, 2013

Food and Drug Administration to market a new drug is a critical waypoint along the path to profits for pharmaceutical manufacturers. In the meantime, lobbyists working for the drug manufacturers successfully blocked efforts by Medicare administrators to stop paying for the higher (harmful) doses. Approval from the U.S.

Manufacturing 130

Manufacturing Family Medicine DO Patients 130

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