FDA Law Blog

JULY 12, 2022

On June 30, individuals with access to the CCP (i.e., 510(k) correspondents for Traditional 510(k)s since the CCP was originated) received an email from CDRH announcing that “Soon, FDA will let you send new CDRH-led premarket submissions online through our Customer Collaboration Portal (CCP) instead of shipping them as physical media.”

Electronics 52

Electronics Individual Specialization Physicals 52

The Clinical Problem Solvers

DECEMBER 16, 2020

Moreover, center patients not only in discussions about individual decision-making but in constructing and drawing meaning from the research. These factors may have impacted their diet, physical activity, and medications, thus impacting their creatinine levels and the inputs that we use for GFR.

Clinic 52

Clinic Education Clinical Practice Patient-Centered 52

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. Kristine: Well, I did have a song, but I was negligent at giving it to him. So, he tried to read my mind… Eric: What was your song? Alex: (singing) Eric: That was wonderful. Kristine: Yeah, yeah, yeah.

Physicals 86

Physicals IT Hypertension Education 86

GeriPal

JULY 19, 2024

What should we use to screen individuals? Summary Transcript Summary The US Preventive Services Task Force (USPSTF) concluded back in 2000 that there is insufficient evidence to recommend for or against routine screening for dementia in older adults. Should it? If so, how do we screen and who do we screen? Who should get it if anyone?

Screening 120

Screening Primary Care Patient-Centered IT 120

FDA Law Blog

MAY 20, 2021

At least two investigators must be present during the on-site inspection, but teams can include DEA special agents or task officers from state and local law enforcement and regulatory agencies. By Larry K. Policies and Procedures. The policies and procedures should include a section on how the registrant handles DEA inspections.

Management 40

Management Consulting Provider Physicals 40

FDA Law Blog

MAY 20, 2021

At least two investigators must be present during the on-site inspection, but teams can include DEA special agents or task officers from state and local law enforcement and regulatory agencies. By Larry K. Policies and Procedures. The policies and procedures should include a section on how the registrant handles DEA inspections.

Management 40

Management Consulting Provider Physicals 40

Mesa Family Physician

MAY 8, 2025

Whether you’re scheduling your annual physical , exploring the differences between a wellness visit vs physical , or simply wondering what’s covered under your insurance, understanding preventive care can empower you to take charge of your health. Annual Physicals: Covered or Not? How long is a physical good for?

Preventative Care 100

Preventative Care Preventive Care Wellness Visit Physicals 100

Medical Xpress

JUNE 16, 2025

A 2024 study published in the journal Nature Medicine found that military veterans with brain injuries saw major mental and physical improvements after just one ibogaine session. The goal is to support clinical trials and bring in another $50 million in private investment to help ibogaine win approval from the U.S. Former Texas Gov.

Mental Health 52

Mental Health IT Medical Specialization 52

Georgetown Pediatrics & Family Medicine

JANUARY 19, 2022

Here are some tips from the American Academy (AAP) to help your family get through the stress of the pandemic. ​ Address children’s fears Children rely on their parents for safety, both physical and emotional. When safe, physically distanced visits aren’t possible, video chats can help ease their anxiety. Look forward.

Physicals 40

Physicals Families Family Management 40

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. So yes, humans make mistakes.

Finance 52

Finance Individual Education Healthcare Professional 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. This achievement is the result of an interdisciplinary collaboration among researchers in life science, physics, and computer science.

Provider 109

Provider Medical Complication Diabetes 109

GeriPal

JANUARY 25, 2024

MOC Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 0.75 MOC points per podcast in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. ABIM MOC credit will be offered to subscribers in November, 2024.

Patient-Centered 123

Patient-Centered IT Illness Patients 123

GeriPal

FEBRUARY 8, 2024

MOC Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 0.75 MOC points per podcast in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. ABIM MOC credit will be offered to subscribers in November, 2024. Alex: Yeah.

IT 137

IT Families Family Physicals 137

GeriPal

OCTOBER 17, 2024

We talk about what is heart failure, particularly HFpEF, how we treat it (including the use of sodium–glucose cotransporter-2 inhibitors (SGLT2’s), and how we should apply guidelines to individual patients, especially those with multimorbidity who are taking a lot of other medications. Because I think we have someone special, a guest host.

Primary Care 114

Primary Care Patient-Centered IT Patients 114

GeriPal

MAY 8, 2025

So in our trial, because of security reasons, we are required by Health Canada to store the substance in a special secure area in my office. We’ll discuss three recent clinical trials involving patients with serious illness, joined by our guests James Downar , Ali John Zarrabi , and Margaret Ross. It’s there. Alex 02:16 Jim Low e.

Illness 109

Illness IT Patient-Centered Patients 109

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. That’s a hard enough task, given that most of us have never had any communication skills training. I’m just so excited about our guests today. Gordon 02:02 I do.

IT 133

IT Illness Families Family 133

GeriPal

FEBRUARY 29, 2024

The hot sauces progressed from mild to extreme (and I mean extreme) heat. Can I just say…it works? Being asked a question with your mouth on fire, sweat streaming down your face, feeling the most awake and terrified you have ever been in your life, forces you to give an unadorned answer, straight from the heart. Lynn: Okay. Anne: GeriPal edition.

IT 127

IT Patient-Centered Illness Education 127

GeriPal

JULY 11, 2024

And, you know, I just thought it was a really special song. Summary Transcript Summary In May we did a podcast on KidneyPal (the integration of palliative care in renal disease) , which made us think, hmmm… one organ right next door is the liver. Maybe we should do a podcast on LiverPal? (or or should we call it HepatoPal?) K idney P al?

Patient-Centered 110

Patient-Centered IT Patients Clinic 110

GeriPal

MARCH 13, 2025

Justin Sanders wants to be sure the newer generations of palliative care clinicians understand the early principles and problems that animated the founders of hospice and palliative care, including: Origins of the word palliative – its not what I thought! If you read just one, read Palliative Medicine – Just Another Specialty ?

IT 105

IT Patient-Centered Families Family 105

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

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

JUNE 16, 2022

We’ve invited some very special guests to talk about the lower urinary tract – Christine Kistler and Scott Bauer. . Very interested in decision making around as we get older, individualizing care, sort of patient centered, values driven, it’s a tough decision to figure out. Chrissy: I do. Alex: Oh, very appropriate.

Management 123

Management IT Medical Patient-Centered 123

GeriPal

FEBRUARY 20, 2025

Kate and Ashwin talked about their research on the prevalence of lifetime trauma and its association with physical and psychosocial health among adults at the end of life. And you can’t really predict how each individual might react to the same experience. Mariah, welcome to the GeriPal Podcast. Mariah 00:29 Glad to be here.

IT 67

IT Patient-Centered Individual Screening 67

Plum Health

OCTOBER 16, 2024

Whether you need a routine physical, vaccination, or management of a chronic illness, this clinic has you covered with a focus on holistic and individualized care. Primary Care for All Ages and Stages of Life This clinic specializes in primary care for patients of all ages. Here’s why everyone is talking about it!

Clinic 52

Clinic Chronic Disease Management Primary Care Medical 52

GeriPal

MAY 9, 2024

He was also the one who we have to thank for suggesting this podcast! Hsien Seow & Samantha (“Sammy”) Winemaker : Hsein and Sammy’s goal was to start a revolution with their podcast “ The Waiting Room Revolution ,” which is now in its 7th season! ABIM MOC credit will be offered to subscribers in November, 2024. Great title. Matt: Same.

Education 128

Education IT Illness Healthcare 128

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. Interestingly, when these are sold, either online or in physical stores, theyre marketed As additives to make your own whipped cream at home. So, what are inhalants? English elite.

Complication 52

Complication Patient-Centered Management Patients 52

GeriPal

MARCH 28, 2024

I’m just stunned even writing that! We’ve come so far as a field. This isn’t to say we’ve “made it” – more to say that we’ve reached a new stage of maturation of the field – in which the evidence we are discussing is frequently high quality randomized trial level data. -@AlexSmithMD Transcript Eric: Welcome to the GeriPal podcast.

Consulting 116

Consulting Patient-Centered IT Patients 116

GeriPal

SEPTEMBER 22, 2022

Coming off as rote and scripted during a serious illness conversation can have a similar off-putting impact on patients and families. Today we talk with Josh about how to anticipate and avoid the uncanny valley. And talk about times when we’ve fallen into it. . Key message: Listen to the music. All the time. ;). We’ll have links to it.

Illness 102

Illness IT Patient-Centered Patients 102

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? Should eligibility and access be determined by clinician referral? By diagnosis? By prognosis? What’s the role of implementation science?

Consulting 100

Consulting Patient-Centered Diagnosis IT 100

GeriPal

APRIL 6, 2023

Practice-PC is an intentionally interprofessional and cutting edge year-long group continuing education course in palliative care for working professionals from all disciplines, in the Bay Area. It meets in-person, once a month, over nine sessions. First, the lyrics, that’s the main reason why I chose it. The theme is death. LaVera: Yeah.

IT 99

IT Patient-Centered Families Family 99

GeriPal

SEPTEMBER 8, 2022

Holly: Oh, thank you, Alex, my star mentee. And it’s a pleasure to be here and to finally meet Eric. Eric: Well, we got a lot to talk about. Before we jump in the topic, do you have a song request for Alex? Holly: Yes, I do. My song request is Come On Up To The House by Tom Waits. Alex: And why this song? That line just kind of tickled me, so.

IT 100

IT Complication Relationship Specialization 100

GeriPal

JUNE 29, 2023

This week we’re going on to episode two, which is for me one of the most special episodes we’ve done in GeriPal for a very, very long time. Eric: And in the end, we have a very special part where we actually get a tour of their gardens outside of the hospice unit. One story that Allan told perfectly sums this up.

IT 97

IT Families Family Board-Certified 97

GeriPal

MARCH 10, 2022

She’s a geriatric nurse practitioner specializing in palliative care, and assistant professor at the University of Maryland School of Nursing. Alex: And we’re delighted to welcome Joan Carpenter, who I just did the State of the Science with at the AAHPM HPNA meeting. Welcome to the GeriPal Podcast, Joan. Joan: Thanks. Bring it on.

Nurse Practitioner 60

Nurse Practitioner Hospital Families Family 60

GeriPal

MARCH 31, 2022

Summary Transcript Summary. In her essay “ Why Read a Poem in a Time Like This? ”, Marilyn McEntyre writes: All of us need it. We need it because good poems do something prose can’t do. They invite and enable us to notice the precarious fissures in what we think is solid ground. I think it’s titled Patient Poets Illness. Eric: Thank you Guy.

IT 70

IT Patients Medical Illness 70

GeriPal

DECEMBER 7, 2023

was supported by the fossil fuel industry , because it shifted responsibility for change from industry to individuals. Summary Transcript Summary To my teenagers, climate change is an existential crisis. It’s the end of the world as we know it. They decry the lack of serious attention and prioritization this issue has in the US.

Healthcare 130

Healthcare IT Education Community 130

Vida Family Medicine

MARCH 1, 2023

Factors such as a history of trauma (abuse, neglect, sexual assault, attachment trauma, etc), life stressors including serious physical or mental illness, and social influences that portray thinness as an ideal and promote dieting combine with an underlying genetic predisposition to contribute to development of an eating disorder.

Mental Health 52

Mental Health Physicals DO Family Medicine 52

GeriPal

JULY 25, 2024

Eric 00:13 And Alex, we have a super special today, three different articles. Alex 00:18 Prognosis, super special today. MOC Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 0.75 ABIM MOC credit will be offered to subscribers in November, 2024.

Families 108

Families Family Patient-Centered Patients 108