FDA Law Blog

JULY 10, 2023

After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review. According to the 2 nd Quarter FY2023 MDUFA V Performance Report , FDA issued a request for additional information (AI request) on the first FDA review cycle for 63% to 68% of 510(k)s submitted in FY2018 to FY2022.

Provider 75

Provider IT Engineering Medical 75

FDA Law Blog

FEBRUARY 28, 2023

We have made improvements to the content of each of these sections over the years and have included additional information to address other guidance documents and the refuse to accept (RTA) checklist, but the general structure has been constant. In other sections of the template, attachments will be needed to include this type of information.

Provider 52

Provider Electronics IT Complication 52

PEMBlog

APRIL 20, 2023

A special thanks to Dr. Cristina Tarango, director of the Hemophilia Treatment Center at Cincinnati Children’s and Lisa Littner, Project Manager at Cincinnati Children’s who helped me research and write this post. …and it’s called Hemlibra (Emicizumab) Why this med is important and why kids are on it? Factor first!

Individual 52

Individual Patient-Centered Patients IT 52

GeriPal

MAY 19, 2022

I know this is like, we’re talking about math and so that makes it all a little complicated, but think about it this way. I really am not buying that it’s too complicated to do A over B, equal C over D, if you know three of the four variables. Part of my proposal is, again, that we can actually use very similar information.

IT 139

IT Patients Individual Relationship 139

GeriPal

JANUARY 12, 2023

After coming out of residency and taking care of lots of complicated older adults as of now, a brand new physician attending, I really needed that team to help me out. Number three, this specialized prepared environment that promotes safe mobility and cognitive stimulation and delirium prevention, so sort of environmental changes.

Hospital 100

Hospital Patient-Centered IT Nurse Practitioner 100

GeriPal

JULY 19, 2024

But the thing that really motivates me is seeing, you know, and trying to manage later stage, you know, we can call them complications of people who haven’t had a diagnosis are now really in, you know, a world of complexity around other conditions, around managing life and managing practical things. Yeah, Medicaid program.

Screening 119

Screening Primary Care Patient-Centered IT 119

StorytellERdoc

MARCH 18, 2020

Friends and family have asked me my thoughts on Covid-19, maybe believing I have some special information simply from being on the front lines. Rightly so, these policies have changed frequently as we sort out the information amid new revelations, details, and statistics as they come in. We are all scared. Don't engage.

ER 100

ER Illness Physicals Provider 100

GeriPal

MAY 11, 2023

It’s just another example of, I think, that there’s a little extra special sauce there in the Beeson program. But I would say that in terms of education, it’s really complicated because it’s so confounded by socioeconomic status and so many social determinants of health. So, that’s one thing.

Physicals 86

Physicals IT Hypertension Education 86

Medical Xpress

JUNE 16, 2025

More information: ScienceDirect has more on ibogaine. Journal information: Nature Medicine © 2025 HealthDay. The content is provided for information purposes only. The information you enter will appear in your e-mail message and is not retained by Medical Xpress in any form. All rights reserved.

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

Provider 110

Provider Medical Complication Diabetes 110

Plum Health

OCTOBER 11, 2024

This guide will help you understand the different types of clinics and services they offer, so you can make an informed decision about where to seek medical care. If you have a chronic condition like asthma, diabetes, or arthritis, unexpected complications or flare-ups can occur at any time. What is in a clinic?

Clinic 52

Clinic Primary Care Doctor Primary Care Chronic Condition 52

Physician's Weekly

JUNE 23, 2025

She called the NIH news “a complicated mix of emotions,” CNN said. “We Allison also noted that the community has also been pushing for an emergency declaration that would give residents access to special Medicare benefits to help pay for medical care tied to chemical exposure, CNN said. We desperately need real medical support.”

Community 52

Community Asthma Engineering Complication 52

Physician's Weekly

JUNE 19, 2025

This is the kind of information we all need, all deserve. Because when Bob calls to check on the prior authorization– PA for short– Well, here’s how he says the conversation went… Bob: ‘Yes, we got the PA information. And maybe we can put a little dent in that. It was denied.’ ’ ‘It was denied?

Insurance 52

Insurance IT Board-Certified Medical 52

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 one of the hardest things is to distill it down to a sentence or two about what is information, what does it mean? This is a complicated case.

IT 132

IT Illness Family Families 132

PEMBlog

JANUARY 16, 2025

As always, Im your host, Brad Sobolewski, and today were diving into an important topic, inhalant misuse, with a special focus on nitrous oxide. Further complicating matters is that each inhalant has its own special risks. Chronic misuse of these results in profound hypokalemia and metabolic acidosis. Thank you for listening.

Complication 52

Complication Patient-Centered Management Patients 52

GeriPal

JANUARY 25, 2024

It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. It used to be a much more complicated model. As a nurse, how challenging would it be to do eight hours of training and jump into this complicated world? Eric: How about you, David?

Patient-Centered 122

Patient-Centered IT Illness Patients 122

GeriPal

SEPTEMBER 7, 2023

So I make the point, they often say, “Oh, you have this special population,” like pediatrics, where it’s 10% or something. We have the chemo talks tool posted, so people can go there and click and immediately get the information about this. What do they do with this information? Do you worry about that?

Patient-Centered 129

Patient-Centered IT Patients Clinic 129

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. The fundamental message of equity and inclusion has informed her research, clinical work, and leadership duties at NYU and beyond.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

GeriPal

JULY 11, 2024

It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. And, you know, I just thought it was a really special song. I’ve seen patients post transplant when they start having complications. They are complicated.

Patient-Centered 109

Patient-Centered IT Patients Clinic 109

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

primary palliative care interventions seem to fail, whereas specialized palliative care interventions have a relatively robust track record of success. But we felt like we want to give like the primary thing about clinical decision support is to give the provider information they don’t already have. Why do so many (most, all??)

Patient-Centered 77

Patient-Centered IT Hospital Patients 77

GeriPal

JUNE 16, 2022

We’ve invited some very special guests to talk about the lower urinary tract – Christine Kistler and Scott Bauer. . I appreciate that information. Eric: So this is a complicated pathway, right? Lots of information in there. Eric: Did that information change your practice at all? Chrissy: Right. Scott: Yeah.

Management 122

Management IT Medical Patient-Centered 122

GeriPal

FEBRUARY 8, 2024

It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. Tell us more about what you mean,” because they give us beautiful information from that. Between those two things, usually you get all the information you need.

IT 137

IT Family Families Physicals 137

GeriPal

MAY 25, 2023

Complicated grief? Sarah: Yeah I similarly feel like, you know, focusing more on the process, the qualitative kind of from a research standpoint, the qualitative information that we’re getting from folks. We don’t push any information at them. Did the caregiver feel heard and understood? Did they have PTSD?

Community 96

Community IT Patient-Centered Primary Care 96

GeriPal

MAY 22, 2025

We start each podcast with a song in part to shift the frame, taking people out of their academic selves and into a more informal conversation. My voice is nothing special. Relationships are usually more complicated. Summary Transcript CME Summary As you know, dear listeners, I love music. Alex 09:00 Not true.

IT 97

IT Patient-Centered Patients Board-Certified 97

GeriPal

JUNE 13, 2024

It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. Midnight special shine a light on me or let the midnight special shine a light on me let the midnight special shine another loving light on me.” Alex 03:31 That was fun.

Illness 133

Illness Patient-Centered Patients IT 133

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.

Family 106

Family Families IT Patients 106

New South Family Medicine and MedSpa

SEPTEMBER 17, 2019

The world of diets and dietary theories is complicated and can be overwhelming. For healthy plate recipes or more information, please visit me at www.faithfullyrootedinhealth.com Follow me on Instagram Here ! in-the-know/our-specials":{"type":"Static","pageId":"u7hat"},"./schedule":{"type":"Static","pageId":"tg6i2"},"./medspa":{"type":"Static","pageId":"hr7g7"},"./meet-the-team":{"type":"Static","pageId":"w0jmf"},".

Referral 40

Referral DO Family Medicine Primary Care 40

GeriPal

AUGUST 11, 2022

We didn’t really have any available information about changing from one opioid to the other, about… Medicines were used in a very unsophisticated way because we just didn’t know any stuff. And so people were just doing whatever they wanted, whatever moved them to do. She’s so responsive.”

Illness 109

Illness IT Family Families 109

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? They need, they need some, a little bit of information and probably a little more than that, what we like to call an edge. By diagnosis?

Consulting 99

Consulting Patient-Centered Diagnosis IT 99

GeriPal

MARCH 28, 2024

We all, when bombarded with information have to take certain elements of a decision and focus on those; and in the ICU, you can imagine, we’re bombarded with information a lot. It’s complicated because right now there’s no mechanism other than cost avoidance. I don’t want to misspeak because now I forget.

Consulting 115

Consulting Patient-Centered IT Patients 115

GeriPal

SEPTEMBER 5, 2024

Alex 15:13 This is really complicated. They have a special skill, and when they see someone who needs it, they need to use it. That makes it really special for them and for me. And it’s not the same, but it does provide information. So I think that was a factor also that they thought, like, this is fixable.

Patients 98

Patients IT Patient-Centered Hospital 98

GeriPal

JULY 25, 2024

It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. Eric 00:13 And Alex, we have a super special today, three different articles. Alex 00:18 Prognosis, super special today. Eric 00:09 Welcome to the GeriPal podcast.

Family 106

Family Families Patient-Centered Patients 106

GeriPal

JUNE 6, 2024

On today’s podcast Areej El-Jawahri, oncologist specializing in blood cancers at MGH, says that sexual health is one of the top if not the top issue among cancer survivors. Alex 00:06 We are delighted to welcome back Areej El-Jawahri, who’s an oncologist at Massachusetts General Hospital who specializes in blood cancers.

Illness 130

Illness IT Physicals Patients 130

FDA Law Blog

JUNE 21, 2022

Under the proposed rule, OTC hearing aids are exempt except “self-fitting” hearing aids, which are subject to testing requirements and special controls. Because of the complicated issues here, as well as the 1100+ comments, many assumed that FDA would need significantly longer than 180 days to publish final regulations.

IT 52

IT Provider Government Patients 52

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. It was information about our ACP facilitator. And that included scheduling a visit with a, with a facilitator who had been specially trained. This is a pragmatic trial.

Primary Care 79

Primary Care IT Clinic Patient-Centered 79

Physician's Weekly

JUNE 13, 2025

Doctors who agree to work for the armed forces receive special benefits. Patients, Health Advocates See More Risk ,” May 23), have pre-vaccine complications such as multisystem inflammatory syndrome in children been forgotten? Please remind people of these serious complications which, though infrequent, cannot be reversed.

Vaccination 52

Vaccination Family Families IT 52