article thumbnail

Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales

FDA Law Blog

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.

article thumbnail

The Most Engaging Decision You’ll Read All Year – Five Stars

FDA Law Blog

Koblitz — You know a court decision is going to be worth reading when the judges compare FDA’s regulatory governance of flavored e-cigarettes to a Shakespearean gaslighting. Let’s just say, the smackdown—er, decision—eviscerates FDA’s approach to regulating flavored e-cigarettes. By David B. Clissold & Sara W.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Is Hospice Losing Its Way: A Podcast with Ira Byock and Joseph Shega

GeriPal

As somebody who has been part of literally more non-profits than I can remember, non-profit governance structures is a pain in the ass. Because no hospice will take a chance on her because she has end stage dementia every time she falls, she’s got to go to the er. (singing) Ira: Thank you very much. ” How is that right?

IT 115
article thumbnail

Ding Dong is the Skinny Label (Effectively) Dead?

FDA Law Blog

Teva case, that the statutory provisions governing patent infringement, specifically induced infringement, do not address carve-outs. Instead, it was GSK who erred in omitting the post-MI language from the use code. The catch is, as we have learned from the GSK v.

IT 52
article thumbnail

PC for People Experiencing Homelessness: Naheed Dosani

GeriPal

You know, we found that 64% of the people we cared for never went to the hospital or ER. Government is not the 51st state. The peach program and our mobile palliative care program for people experiencing structural vulnerabilities. And so the metrics kind of spoke for itself.

article thumbnail

Allowing Patients to Die: Louise Aronson and Bill Andereck

GeriPal

So elderly people who aspirated, got pneumonia, had an mi, didn’t get hauled off to the emergency room on an ambulance crew so they could die in the ER. Eric 42:11 But how much of it is like Winston Churchill, like, democracy is the worst form of government. The intention was to place it in the beds in nursing homes.

article thumbnail

The Promise and Pitfalls of AI in Medicine: Guest Bob Wachter

GeriPal

I think a lot of back office function, predicting ER loads and OR loads to do better scheduling of staff. And it happened, and it happened in large part, as you note, because of enormous stimulus from the US government for health systems to adopt electronic health records. Similar things will happen with AI, without question.

IT 140