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

In This Issue : Why Renewable Energy Belongs in Every Clinic Medical Waste: One Model for Improvement OnTrack with your Sustainability Goals? Latest news & breaking headlines And, in many countries, governments offer financial incentives to install solar panels and even backup batteries. Looking for a tailored approach?

Healthcare 52

Healthcare Healthcare Professional Consulting Management 52

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). FDCA § 513(f)(5).

Manufacturing 52

Manufacturing Specialization Government IT 52

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

Physician's Weekly

JULY 3, 2025

But the administration is seeking to cut government funding that could serve as a counterweight. Trump’s budget proposes spending $500 million “to tackle priority activities to Make America Healthy Again,” including $260 million for his new Administration for a Healthy America to address the “chronic illness epidemic.”

Chronic Disease 52

Chronic Disease Government Engineering IT 52

FDA Law

APRIL 21, 2021

In support of this proposal, the Notice looked only to FDA’s publicly available device adverse event database, FDA’s Manufacturer and User Facility Device Experience (MAUDE), to identify any safety risks. When this author read the January Notice, it seemed like an ill-thought-out proposal. The comment period closes May 17, 2021.

Manufacturing 40

Manufacturing Government IT Consulting 40

FDA Law

JANUARY 9, 2024

This request must provide details about, among other things: The foreign seller that will purchase the prescription drug directly from its manufacturer, along with invoices, batch, and lot/control numbers to verify the sale and the units sold. The government would require at least another 30 days to examine the shipment at the U.S.

Supply Chain 59

Supply Chain Manufacturing Chronic Condition Government 59