FDA Law Blog

FEBRUARY 29, 2024

8,128,929 was submitted on December 8, 2016 (Docket No. FDA-2017-E-5106 ), and concerns FDA’s October 19, 2016 Accelerated Approval of BLA 761038 for LARTRUVO (olaratumab). While that’s quite a while ago, the file was complicated by a fight over the IRTNMTA (see our previous post here ). The PTE application for U.S.

Clinic 59

Clinic IT Provider Patient-Centered 59

Annals of Family Medicine

NOVEMBER 20, 2024

Context: Complications contribute to significant type 2 diabetes mellitus (T2DM) morbidity. While preventable, many fail to receive timely treatment in primary care, leading the most vulnerable to accumulate complications. Results: We included 49,843 individuals in model 1.

Complication 130

Complication Diabetes Primary Care Utilities 130

GeriPal

JUNE 30, 2022

Should she have an operation, and risk the pain, potential complications, and attendant delirium associated with the operation? And I came to the now I think naive conclusion that fixing and avoiding complications was the secret. They were more likely to have a major inpatient surgical complication. She falls and breaks her hip.

Patient-Centered 101

Patient-Centered Complication Patients IT 101

GeriPal

APRIL 10, 2025

I think back in what, May 2016, you published a randomized controlled trial, first author, palliative care and the ED randomized study, cancer patients. Eric 04:26 So that 2016 study was in the ED, but it was getting specialty palliative care to see them when they were hospitalized, is that right? But yeah, it’s complicated.

Patient-Centered 78

Patient-Centered IT Hospital Patients 78

GeriPal

MARCH 28, 2024

Eric: And that’s similar to the 2016 JAMA paper, right? Eric: And we’re going to get to results, but that’s why I also love that 2016 paper: I think it was the very first palliative care trial that ever looked at individuals getting curative therapy. Did it negate everything from the 2016 trial?Palliative

Consulting 116

Consulting Patient-Centered Patients IT 116

GeriPal

JANUARY 11, 2024

The number of people who have used MAID in Canada since it was legalized in 2016 has increased year on year from about 1,000 people in the first year to over 13,000 people in 2022. In 2016 there were about a thousand MAID deaths, in 2021 there were about 10,000. Four percent. So figured out a little harmonica- Eric: That was wonderful.

Illness 144

Illness IT Medical Provider 144

GeriPal

FEBRUARY 15, 2024

Wait, first of all, what’s the incidence of calling EMS for falls over almost a decade, I think like 2007 to 2016, and what happens to people afterwards? Eric: So you both published a paper in JAGS, what, 2018, ’19 looking at what happens to people? You want to go back, I know this is pre-pandemic. Alex: The Wayback Machine.

Community 116

Community Transportation IT PCP 116

GeriPal

MARCH 30, 2023

Then in the OpenNotes work that I do, I was hired to take something complicated like transparency and patients having access to their full records in medicine, and then making that something that the lay public understood. As I was cleaning up my office, I found something I’d written in 2016. What happened here?

IT 96

IT Patient-Centered Patients Healthcare 96

GeriPal

AUGUST 24, 2023

Had multiple physical, psychological complications as a result of that. That the wish to… Eric: Complicated. Harvey: Complicated. And intensive caring, I think, acknowledges that the wish to die, human suffering is complicated. My oldest sister who I’ve written a little bit about, her name was Ellen.

Patient-Centered 98

Patient-Centered Patients IT Illness 98

GeriPal

JULY 28, 2022

Areej: I think it was 2016. Eric: 2016. Jennifer: I think it’s such a complicated question. I loved Areej’s article. What year did it come out? Actually think I wrote the editorial for that article. I loved it so much. What year did it come out?

Illness 111

Illness Hospital Patient-Centered Patients 111

GeriPal

AUGUST 25, 2022

It would be great to have a one-stop shop because life is complicated enough when you’re trying to live in and enjoy the time you have left, and adapt to all the changes that are happening. They only started having to publicly report these in 2016. It waxes and it wanes. There’s a lot of geriatric needs.

Families 107

Families Family IT Patients 107

FDA Law Blog

MAY 21, 2024

We wondered how given that HHS and the Drug Enforcement Administration (“DEA”) conducted eight-factor scheduling analyses in 2016, concluding that there was “no substantial evidence that marijuana should be removed from Schedule I.” 12, 2016) ; Denial of Petition to Initiate Proceedings to reschedule Marijuana, 81 Fed. 12, 2016).

Physicals 69

Physicals Medical Clinic Emergency Room 69

GeriPal

JULY 25, 2024

God, it must have been like 2015, 2016. And as things sometimes happen in surgery, patients can experience complications and one complication, particularly in someone who’s frail, who’s not buying the cabbage, maybe they’re buying the chard at the farmer’s market. Kara 10:12 Yep.

Families 108

Families Family Patient-Centered Patients 108

GeriPal

JANUARY 5, 2023

Robert was first asked by one of his own patients for assistance in dying in 1991, far before aid in dying was legalized in California in 2016. We start by talking with Robert Brody, an internist who recalls physicians helping patients die during the height of the AIDS epidemic in San Francisco.

Provider 19

Provider Medical Hospital Patient-Centered 19