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.

Provider 75

Provider IT Engineering Medical 75

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 119

Screening Primary Care Patient-Centered IT 119

Mesa Family Physician

MAY 8, 2025

Why Preventive Health Maintenance Matters The importance of public health and individual wellness cannot be overstated. If you have insurance through providers like Blue Cross Blue Shield , coverage generally includes one annual physical per calendar year. The goal is to avoid disease, not just treat it. are all common concerns.

Preventative Care 100

Preventative Care Preventive Care Wellness Visit Physicals 100

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. But what we observed was much more complicated." The content is provided for information purposes only.

Provider 109

Provider Complication Medical Diabetes 109

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

The Clinical Problem Solvers

FEBRUARY 8, 2023

There is a special emphasis on the use of public health models that prioritize harm reduction and person-centered care to prevent drug-related fatalities and curb the opioid epidemic along lines of race and class. They can use their training and privilege to advocate for meaningful policy reform.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

The Clinical Problem Solvers

APRIL 5, 2022

During this episode, we gained insight from special guests Dr. Margot Kushel and Mr. Bobby Watts about what brought them into their fields, how their work reaches the most marginalized, and what can be done at the community and structural level to address homelessness. Push back against dehumanizing language.

Community 52

Community Patient-Centered Emergency Room Medical 52

GeriPal

JANUARY 25, 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. David: Right.

Patient-Centered 122

Patient-Centered IT Illness Patients 122

GeriPal

JULY 11, 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.

Patient-Centered 109

Patient-Centered IT Patients Clinic 109

PEMBlog

JANUARY 16, 2025

Learn how to recognize and manage cases in the emergency department, ask the right questions to uncover inhalant use, and provide critical resources for prevention and support. As always, Im your host, Brad Sobolewski, and today were diving into an important topic, inhalant misuse, with a special focus on nitrous oxide.

Complication 52

Complication Patient-Centered Management Patients 52

GeriPal

MAY 25, 2023

Complicated grief? And I’ll just say that I think what we know is there’s been so much greater advance care planning research and and at many levels, at a at an individual level, at a health system level, at a policy level. Did the caregiver feel heard and understood? Did they have PTSD? Depression?

Community 96

Community IT Patient-Centered Primary Care 96

GeriPal

AUGUST 29, 2024

We must often deliver complex medical information that carries heavy emotional weight in pressured settings to individuals with varying cultural backgrounds, values, and beliefs. And for many years, I think there was a focus on physicians and then providers. Summary Transcript CME Summary Serious illness communication is hard.

IT 132

IT Illness Families Family 132

GeriPal

AUGUST 25, 2022

Eric: Alex, we have a super special today. We’ve got a hospice super special. Alex: We have a hospice super special day. Eric: We have a smorgasbord, if you will, of papers that got published recently around hospice, and that’s why we’re calling it a hospice super special. -@AlexSmithMD. Transcript.

Families 106

Families Family IT Patients 106

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 110

Illness Hospital Patient-Centered Patients 110

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. But yeah, it’s complicated.

Patient-Centered 77

Patient-Centered IT Hospital Patients 77

GeriPal

JUNE 16, 2022

For example, we once thought that the lower urinary tract was sterile, but we now know it has its own microbiome, which may even provide protection against infections. We’ve invited some very special guests to talk about the lower urinary tract – Christine Kistler and Scott Bauer. . Eric: So this is a complicated pathway, right?

Management 122

Management IT Medical Patient-Centered 122

GeriPal

FEBRUARY 8, 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.

IT 137

IT Families Family Physicals 137

New South Family Medicine and MedSpa

SEPTEMBER 17, 2019

The world of diets and dietary theories is complicated and can be overwhelming. However, people need to understand what works best for them individually. Eating fruit provides excellent health benefits and is part of a healthy plate. Fruits provide nutrients vital for health and maintenance of your body.

Referral 40

Referral Family Medicine DO Primary Care 40

GeriPal

SEPTEMBER 8, 2022

And also it’s a little bit of an insult to one’s identity to feel like if this special person in your life can be forgotten, then you can be forgotten. But our living memory home is a way to both maintain that connection, because that’s the fear is that you’re going to lose this connection to this very special person.

IT 100

IT Complication Relationship Specialization 100

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 115

Consulting Patient-Centered IT Patients 115

GeriPal

MARCH 30, 2023

This week we’ve invited three guests to share their stories about storytelling that’s written for healthcare providers. 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.

IT 96

IT Patient-Centered Patients Healthcare 96

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? That gets really complicated as well. Alex: It gets very local and individualizes as you were saying. By diagnosis? By prognosis?

Consulting 99

Consulting Patient-Centered Diagnosis Referral 99

GeriPal

JULY 25, 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.

Families 106

Families Family Patient-Centered Patients 106

GeriPal

MAY 1, 2025

Have been now a care provider for people with HIV for over 40 years. And I became more and more involved in it, including becoming involved in research and developing some of the programs initially to provide care for people with both drug use and HIV related problems, women with HIV vulnerable populations.

Primary Care 94

Primary Care IT Clinic Provider 94

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. It’s a lot.

Primary Care 79

Primary Care IT Clinic Illness 79

GeriPal

JANUARY 5, 2023

“Typically when we think about conscience in medical ethics we think about it in terms of a negative claim of conscience, where a clinician refuses (or objects) to provide care. Lisa was writing about providing abortion care, but she just as easily could have been writing about providing medical aid in dying in states where it is illegal.

Provider 19

Provider Medical Hospital Patient-Centered 19

GeriPal

SEPTEMBER 14, 2023

And we would provide ongoing longitudinal care to them in the home, much like the Mount Sinai Visiting Doctors programs, and other programs like that. And the treatments are different than what hospice might provide in the home setting. I trained at Hopkins. We had, since the late seventies, a home-based primary care program.

Hospital 115

Hospital Patient-Centered Supply Chain IT 115