FDA Law Blog

JULY 7, 2024

Timeliness is critical not only for developing appropriate corrective actions but also for evaluating and, when necessary, submitting reportable events to FDA as discussed below. establish and maintain adverse event files.” [9] report certain device malfunctions, and. MDRs must be reported to FDA in electronic format.

Manufacturing 64

Manufacturing Provider Physicals Electronics 64

GeriPal

FEBRUARY 15, 2024

The insight started when Carmen, an orthopedic surgeon-researcher, and Katie, a physical therapist- researcher participated in ride-alongs with EMS providers to patient’s homes. And one person even called the system 75 times and that was just a light-bulb event for me. laughter] Carmen, welcome to the GeriPal podcast!

Community 114

Community Transportation IT PCP 114

GeriPal

OCTOBER 26, 2023

Physical therapy had walked with him that day and noted improvement compared to previous walks, suggesting that he should be discharged to a skilled nursing facility for rehabilitation on discharge. At the end of the day, I lamented that physical, occupational, and speech therapists aren’t more tightly integrated with palliative care teams.

Patient-Centered 132

Patient-Centered Hospital Patients IT 132

GeriPal

OCTOBER 12, 2023

I’m just wondering, how do we get surgeons, and maybe, how do we teach surgical trainees to move away from this fix-it mentality into the space of deliberation where deliberation is actually invited and prioritized in the surgical consultation? People think of the phases of a typical clinical consultation. ” Eric: Yeah.

IT 128

IT Family Families Patient-Centered 128

GeriPal

OCTOBER 20, 2022

I think what we are starting to find with antibiotics, especially in older adults, is with increasing duration as well as increasing dose, older adults are especially susceptible to adverse events associated with the drugs as well as other risk factors like C. difficile infections. Devika: Thank You. Eric: Thank you.

Complication 52

Complication Patient-Centered IT Patients 52

GeriPal

OCTOBER 5, 2023

I point this out a lot more nowadays to the resident teams that consult. If the consult is for “code status,” I always ask them, take a look at your past conversations. It’s such a physical act, showing just how strong doctor’s moral resolve is to save a life. But we gave it as an option. Sunita: I know.

Illness 136

Illness IT Patient-Centered Family 136

GeriPal

MARCH 6, 2025

And this is really traumatic event for his street family and the street community that he knew. They want you to recognize their pain, not just their physical pain, but their trauma that they’ve experienced as a, as a, as a result of being on the streets. How do you actually physically find them if that’s the case?

Healthcare 100

Healthcare IT Community Illness 100

FDA Law Blog

JULY 9, 2024

This could be based on differential pharmacokinetics (“PK”) or pharmacodynamics (“PD”), possible differences in susceptibility to specific adverse events of concern, or due to differential presentation of the disease or condition. FDA encourages sponsors to consult patients and healthcare providers to assist in developing such strategies.

Clinic 59

Clinic Provider Individual IT 59

GeriPal

MARCH 13, 2025

Alex Smith Links Link to the McGill National Grand Rounds Series on Palliative Care , Michael Kearney as initial presenter, and registration for future events. Ive got a name. No, you dont need to be Canadian. Canadians are welcoming. Palliative Medicine – Just Another Specialty? Sue 13:11 The Royal Victoria Hospital, Montreal.

IT 104

IT Patient-Centered Family Families 104

GeriPal

JUNE 22, 2023

Through a series of events, I started working as a consultant to the Department of Corrections in around 2006, and I was assigned to the California Medical Facility. Welcome to the GeriPal podcast, Michele. Michele: Thank you for having me. Eric: And you’re also the medical director of the hospice unit here. Michele: Yep.

Family 132

Family Families IT Community 132

GeriPal

SEPTEMBER 19, 2024

Alex 10:53 Yeah, or like palliative care if they get a consult for whatever reason, but not trn consult, like standardized, you know, randomized to palliative care versus whatever they’re doing before. If they get palliative care consult, they get one. It’s not just about physical symptom management.

Patient-Centered 119

Patient-Centered IT Patients Hospital 119

GeriPal

SEPTEMBER 5, 2024

So in some ways, it was an iatrogenic event. There was also a second event in that the pressures chosen weren’t the ideal ones. I mean, obviously nobody fed her the pill with the intention of choking her, but it wasn’t like suddenly she had another event out of the blue because she had a bad heart. Eric 46:49 Yeah.

Patients 98

Patients IT Patient-Centered Hospital 98

GeriPal

JULY 25, 2024

Eric 04:39 Yeah, I see it used on inpatient, side on consult clinics in hospices. So how physically active the patient is, how much time they spend awake, how much they’re eating, how much care they need, that type of thing. And since starting the clinic, median time for consult to death was. Eric 10:44 No, all consults.

Family 106

Family Families Patient-Centered Patients 106

GeriPal

NOVEMBER 3, 2022

So people are less able to have the language when the loss event actually happens. And we’ve been really private of doing the research of really doing the deeper thinking about what the loss event happens during the loss event and how we can impact how grief is experienced later. And we don’t talk about it as much.

Healthcare Professional 102

Healthcare Professional Healthcare IT Relationship 102