FDA Law Blog

JULY 10, 2023

By Day 100 If MDUFA Decision is not reached by Day 100, FDA provides Missed MDUFA Decision Communication that identifies outstanding review issues. These AI requests often address complicated scientific scenarios in which a submitter has already provided some information, but FDA is not completely satisfied.

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Provider IT Engineering Medical 75

FDA Law Blog

FEBRUARY 28, 2023

FDA announced on October 3, 2022 that the voluntary electronic Submission Template And Resource (eSTAR) templates would be required beginning October 1, 2023, as we blogged about here. There are additionally places to provide attachments for test reports and other supporting documents. Performance Testing Summaries No Longer Needed?

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Provider Electronics IT Complication 52

Mesa Family Physician

MARCH 6, 2025

Understanding how to prepare for this important appointment ensures you receive maximum benefit from your healthcare provider’s expertise. Identifying health concerns before symptoms appear gives us tremendous advantages in treatment success and minimizing long-term complications.

Preventive Care 100

Preventive Care Preventative Care Appointment Screening 100

Annals of Family Medicine

NOVEMBER 20, 2024

Objective: 1) Demonstrate the feasibility of collecting data from prescription drug monitoring programs (PDMPs) for population health reporting, 2) analyze trends in PDMP and electronic health record patient data relative to CDC guidelines and 3) identify use of patient-centered measures for pain management in primary care.

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Patients Patient-Centered Primary Care Electronics 130

Medical Xpress

JUNE 16, 2025

But what we observed was much more complicated." The content is provided for information purposes only. The traditional model is simple: SCN neurons were believed to act like runners in a relay race, passing the light signal along in a linear chain. Some SCN neurons were activated by light, while others were inhibited.

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Provider Medical Complication Diabetes 110

Medical Xpress

JUNE 16, 2025

The content is provided for information purposes only. Citation : Texas invests $50M in psychedelic drug research to treat addiction (2025, June 16) retrieved 16 June 2025 from [link] This document is subject to copyright. Your feedback is important to us. However, we do not guarantee individual replies due to the high volume of messages.

Mental Health 52

Mental Health IT Medical Specialization 52

GeriPal

JULY 21, 2022

If they’re in a major car crash, they’re going to have more long-term complications probably than a 20-year-old would. But I think then the other factor in this that makes it complicated is the decision for someone in Manhattan might be very different than the decision for someone in, like, rural Wyoming.

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Families IT Family Diagnosis 102

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

SEPTEMBER 7, 2023

So pretty soon, I hope, we’ll be able to do this all electronically by anyone who wants to. Or electronically, to fill out, right? But I mean, I would also add that not all of the responses to the PGA, and to the provider part that is completed, are coming from the patient. So there is no paper and pencil at all.

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Patient-Centered IT Patients Clinic 130

GeriPal

APRIL 10, 2025

Most emergency providers wanted to do the right thing for seriously ill patients, but they didnt have the knowledge, skills, or experience to do it. We weren’t randomizing providers or patients. Corita 09:39 Yeah, so we used the electronic health record, I think, in support. Yeah, that’s a more complicated story.

Patient-Centered 78

Patient-Centered IT Hospital Patients 78

GeriPal

JUNE 15, 2023

Audio: [electronic voice] Alex Smith has been taken over by an artificial intelligence. I think the AI can allow for that complexity but still provide some guidance. This is Eric Widera. Eric: I’m not sure if people could hear that, but that’s artificial intelligence – Alex Smith is here.

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IT Patient-Centered Patients Healthcare 100

GeriPal

JULY 28, 2022

The model is predominantly physicians, advanced practice providers. We needed to build the relationships and trust and really provide a really good example of the value of palliative care outside of end of life care and advanced care planning. Jennifer: I think it’s such a complicated question.

Illness 111

Illness Hospital Patient-Centered Patients 111

GeriPal

MAY 15, 2025

At one end of the spectrum you can provide decision makers with information that doesn’t work very well in most contexts. These were EHR documents in the patient’s chart built within the Atrium Health’s electronic health record, where they document other things. I think it’s good to place nudges in context.

Patient-Centered 118

Patient-Centered Hospital IT Illness 118

GeriPal

OCTOBER 19, 2023

And we were able, because of the way OHSU has the registry and POLST link had just been integrated into our electronic medical records. So you can actually quantify how often it was accessed, at least by either calling the registry or clicking in the electronic record. Eric: That’s a complicated form then.

Patient-Centered 127

Patient-Centered IT Patients Illness 127

GeriPal

MARCH 28, 2024

Kate: The problem is we communicate late, we share prognosis late, we elicit goals and values late, so all the time while they’re in the ICU getting prolonged intensive care, we don’t really know that we’re providing goal concordant care, so we wanted to nudge it a little upstream. Eric: Nudge it. Kate: Nudge it.

Consulting 116

Consulting Patient-Centered Patients IT 116

GeriPal

JUNE 9, 2022

Kate: You just embed it into routine care and workflows, and you really aim for a broader population,, outcomes that are routinely collected care that can be provided in the course of routine care, and not trying to manipulate and control all of the factors. That gets really complicated as well. Alex: Yeah. Eric: So a nudge.

Consulting 100

Consulting Patient-Centered Diagnosis IT 100

GeriPal

SEPTEMBER 5, 2024

Alex 15:13 This is really complicated. And it’s not the same, but it does provide information. And in fact, after a complicated ethics issue, we will oftentimes go in and try and debrief them. So I think that was a factor also that they thought, like, this is fixable. This shouldn’t have happened.

Patients 98

Patients IT Patient-Centered Hospital 98

FDA Law Blog

MAY 21, 2024

The Attorney General also released DOJ’s Office of Legal Counsel (“OLC”) opinions providing the rationale and support for the NPRM. Public comments must be submitted electronically or postmarked on or before July 22, 2024, 60 days after publication in the Federal Register. 44,597 (May 21, 2024). 21 U.S.C. § NPRM at 44,607.

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Physicals Medical Clinic Emergency Room 69

GeriPal

MARCH 27, 2025

But the process of implementing this project across two big health systems in our area was very complicated and had its share of both challenges and rewards. And so a lot of it was the facilitators calling out with the approval of the provider to the patients ahead of time to see, like, you have a visit coming up. Eric 22:03 Okay.

Primary Care 80

Primary Care IT Clinic Illness 80

GeriPal

FEBRUARY 24, 2022

And I think the advanced planning debate is really a question of, how do we help this very complicated situation? And I also think, we still operate under pay for… We get paid for the services we provide, right? We see how hard it is. We see when they don’t understand. We wonder if they were told. Eric: Yeah. Eric: Yeah.

Illness 98

Illness Patient-Centered IT Patients 98

Physician's Weekly

JUNE 17, 2025

Prior authorization varies by plan but often requires patients or their providers to get permission (also called precertification, preauthorization, or preapproval) before filling prescriptions, scheduling imaging, surgery, or an inpatient hospital stay, among other expenses. . ” An Unintended Consequence of Health Reform?

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Insurance Patients Behavioral Health Services Diagnose 52