FDA Law

AUGUST 30, 2021

We have previously posted blogs about FDA’s increasing interest on cybersecurity both in the premarket (see our past blog posts here , here , and here ) and the postmarket space (see our past blog posts here and here ). FDA is now expanding its cybersecurity effort in servicing of medical devices.

Medical 52

Medical Manufacturing Diagnose Healthcare 52

FDA Law

SEPTEMBER 21, 2022

This led to delays in releasing a uniform policy and templates for COVID-19, as well as many other problems (see blog post chronicling some of the challenges here ). On the same day, September 7, CDRH published a policy for monkeypox tests. We note that this policy defines an “experienced developer” more narrowly than the COVID-19 policy.

Manufacturing 52

Manufacturing Diagnose Diagnosis IT 52

Common Sense Family Doctor

FEBRUARY 15, 2025

On Sensible Medicine, Dr. Edward Livingston pointed out that the manufacturer, AbbVie, spent $580 million on DTCA for this drug in 2023, or $290 for each of the 2 million potential patients in the United States. The annual price of risankizumab is $288,000, so this is still a huge bargain for the company given the potential returns.

Family Physician 40

Family Physician Manufacturing Family Families 40

FDA Law

SEPTEMBER 28, 2022

Thus, this decision serves as a reminder that the issuance and wording of FDA safety notices can potentially impact the civil liability exposure of the customers of medical device manufacturers.

Provider 59

Provider Hospital Manufacturing Patients 59

FDA Law

JUNE 4, 2025

The Assessment highlights various trends related to chronic disease diagnoses (such as increasing rates of autism spectrum disorder and attention deficit hyperactivity disorder) with associated trends in prescribing practices. That leaves us to speculate what the implications of this Assessment will be.

Chronic Disease 59

Chronic Disease Government Chronic Condition Clinic 59