FDA Law Blog

DECEMBER 4, 2023

The government asserted additional allegations that are outside our scope. Prescribing Red Flags The government alleged that from at least 2017 to April 2021 Defendants knowingly filled controlled substance prescriptions “that raised obvious ’red flags’ of potential abuse or diversion.” Zarzamora Press Release. Complaint ¶ 55.

Treatment Plan 139

Treatment Plan ER Government Patient-Centered 139

FDA Law Blog

FEBRUARY 27, 2025

E6(R3) specifically acknowledges the rise of innovative trial designs such as adaptive and decentralized methods, while also encouraging the use of electronic informed consent and remote monitoring. How regulators will interpret and enforce its provisions may not become clear for some time.

Clinical Practice 88

Clinical Practice Clinic Government Management 88

33 Charts

OCTOBER 2, 2021

A few ideas: Stronger technology governance of MyChart messages We want to call the MyChart mushroom an Epic problem. Helping patients understand how to manage a system’s communication wardrobe will go a long way in improving the satisfaction of their encounters. It’s everything written here about electronic health records.

Patients 75

Patients IT Provider Family Doctor 75

Permanente Medicine

MAY 20, 2025

Nguyen shared the multiple benefits of an AI ambient listening tool — recently rolled out nationally to more than 25,000 Permanente physicians — that transcribes office visits (with patient consent) that can be edited and added to electronic health records. I know for a fact that the government or legislators looked to us in Permanente.

Patient-Centered 52

Patient-Centered Patients IT Medical 52

GeriPal

JULY 19, 2024

But the thing that really motivates me is seeing, you know, and trying to manage later stage, you know, we can call them complications of people who haven’t had a diagnosis are now really in, you know, a world of complexity around other conditions, around managing life and managing practical things. But I don’t.

Screening 119

Screening Primary Care Patient-Centered IT 119

FDA Law Blog

MARCH 20, 2022

To clarify what preparations companies should take to more seamlessly manage a recall, on March 2, 2022, FDA published its Final Guidance Document on Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C.

Electronics 40

Electronics Manufacturing Provider IT 40

GeriPal

JANUARY 20, 2023

There have been multiple subsequent government reports on nursing home care, most recently was about eight, nine years ago from the OIG. Part of it’s what Mike was saying, it’s accountability as a country, as a nation and as the government. I’m the project manager, so my job’s to zoom in. Eric: Great.

Finance 95

Finance Board-Certified IT Provider 95