FDA Law Blog

MAY 4, 2023

In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories. With regard to clinical trial visits and activities, the draft guidance provides examples of the types of approaches that may be possible with a DCT.

Clinic 59

Clinic Telehealth Provider Electronics 59

GeriPal

JULY 19, 2024

What should we use to screen individuals? Joe 03:55 You know, my thoughts are screening is important for a variety of reasons, and certainly Doctor Boris and Soo and Anna, Doctor chodos can provide a lot greater clinical insight than I. Eric 19:56 Okay, but I’m a primary care provider. Who should get it if anyone?

Screening 120

Screening Primary Care Patient-Centered IT 120

FDA Law Blog

JULY 10, 2023

Understanding the Traditional 510(k) Review Timeline There are three types of Premarket Notification 510(k)s: Traditional , Special , and Abbreviated. By Day 100 If MDUFA Decision is not reached by Day 100, FDA provides Missed MDUFA Decision Communication that identifies outstanding review issues.

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Provider IT Engineering Medical 75

FDA Law Blog

MAY 20, 2021

We are providing a post in three parts on cyclic and on-site inspections in which we focus on the background of inspections, how investigators conduct them, and how registrants should proactively prepare for and manage them. The investigators select the drugs they will audit.

Management 40

Management Consulting Provider Physicals 40

FDA Law Blog

MAY 20, 2021

We are providing a post in three parts on cyclic and on-site inspections in which we focus on the background of inspections, how investigators conduct them, and how registrants should proactively prepare for and manage them. The investigators select the drugs they will audit.

Management 40

Management Consulting Provider Physicals 40

Medical Xpress

JUNE 16, 2025

The content is provided for information purposes only. However, we do not guarantee individual replies due to the high volume of messages. 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.

Mental Health 52

Mental Health IT Medical Specialization 52

Medical Xpress

JUNE 16, 2025

What is known is that special cells in the eye called intrinsically photosensitive retinal ganglion cells (ipRGCs) detect blue light and send signals to the SCN to reset the clock. The content is provided for information purposes only.

Provider 109

Provider Medical Complication Diabetes 109

The Motivated MD

SEPTEMBER 19, 2024

For the better half of 2024, I have been periodically writing posts that are individual articles that double as potential chapters to a future book. Before we discuss each individual savings account, let us first highlight exactly what it means to ‘automate’ your savings. Saving money is simple but not easy.

Finance 52

Finance Individual Education Healthcare Professional 52

GeriPal

FEBRUARY 29, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. Alex: Okay.

IT 127

IT Patient-Centered Illness Education 127

PEMBlog

MARCH 27, 2024

My special guest podcaster, Emily Groopman, is an actual Pediatric Geneticist in training and we hope that you will find this episode useful. So my special guest host on this episode is a trainee in pediatrics and medical genetics. In other words, which features of the disease individuals with the mutation show for these conditions.

Consulting 59

Consulting Individual Families Family 59

GeriPal

JULY 28, 2022

Alex: And we are also delighted to welcome Areej El-Jawahri, who is an oncologist at Massachusetts General Hospital as well, who specializes in blood cancers. So I really opted to specialize in lung cancer because I thought that was the appropriate population to build a supportive and palliative care research agenda. Jennifer: Thanks.

Illness 111

Illness Hospital Patient-Centered Patients 111

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. primary palliative care interventions seem to fail, whereas specialized palliative care interventions have a relatively robust track record of success. Why do so many (most, all??)

Patient-Centered 78

Patient-Centered IT Hospital Patients 78

GeriPal

APRIL 4, 2024

Arguing for the state of Missouri against the Cruzan’s was Ken Starr, who would later be assigned the role of special prosecutor in the investigation of the Clintons (Whitewater, Lewensky, etc). Eric: And Laurie for this patient, were you the outpatient provider? In 1990 the Supreme Court ruled…for the state of Missouri.

Families 113

Families Family Patient-Centered IT 113

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 IT Patients 116

GeriPal

APRIL 6, 2023

To provide context, we are joined by Karen Steinhauser, a social scientist at Duke who has been studying spirituality for years (and published one of the most cited papers in palliative care on factors considered important at the end of life , as well as one of my favorite qualitative papers to give to research trainees ). Lexy: Yeah.

IT 99

IT Patient-Centered Families Family 99

GeriPal

JUNE 9, 2022

We talk with Kate about how despite how far we’ve come in palliative care research, we still don’t have answers to some fundamental questions, such as: Who should get specialized palliative care? But there’s no real system and systematic electronic way to identify need-based palliative care right now. By diagnosis? Alex: Yeah.

Consulting 100

Consulting Patient-Centered Diagnosis IT 100

GeriPal

MARCH 27, 2025

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. And is it at all individualized to the patient? Danny 12:07 I don’t know how individualized it is. This is what I do here. It’s a lot. Yeah, yeah.

Primary Care 80

Primary Care IT Clinic Illness 80

GeriPal

JULY 20, 2023

What was life for you as a provider pre-pandemic? If we’re going to get really academic, that’s the umbrella, and that can include a lot of things like including phone calls between a provider and a patient or messages in someone’s electronic medical record. What did we learn during the pandemic? Eric: Yeah.

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Telemedicine Telehealth Patient-Centered Board-Certified 73