FDA Law Blog

JUNE 21, 2023

enable individuals to have virtual consultations with healthcare providers through video calls or online platforms), at-home diagnostics (e.g., How can the FDA facilitate individuals accessing medical technologies in remote locations when they are unable or unwilling to access care in clinical settings?

Medical 45

Medical Patients Healthcare Electronics 45

FDA Law Blog

JUNE 27, 2024

By Larry K. DEA recently revoked the registration of Coconut Grove Pharmacy (“Coconut Grove”), like Gulf Med Pharmacy also in Florida, for its failure to resolve prescribing red flags and document such resolution. Coconut Grove Pharmacy; Decision and Order, 89 Fed. 50,372 , 50,377 (June 13, 2024). Red Flags at Issue a. monthly for a year.

Insurance 52

Insurance Patients Utilities Chronic Condition 52

FDA Law Blog

JUNE 16, 2023

The statute confuses the issue by providing that “every individual transaction in violation of [the excessive price increase prohibition] is considered a separate violation,” making it unclear whether this is a per-day or per-transaction penalty, and, if the latter, what the transaction is. Is it an increase in AWP/SWP? Best price?

Manufacturing 45

Manufacturing Provider Consulting IT 45

FDA Law Blog

APRIL 23, 2023

The Draft Guidance recommends that, where possible, the outcome should be assessed by individuals blinded to treatment status, which may require re-adjudication of externally controlled data. This Draft Guidance focuses on the use of patient-level data from other clinical trials or from RWD sources.

Patient-Centered 49

Patient-Centered Clinic Patients Provider 49

FDA Law Blog

SEPTEMBER 20, 2021

First, CDER will publish a new MAPP (the Manual for Policies and Procedures, meant to guide CDER staff in their review activities and interactions with sponsors) describing: (1) early engagement with sponsors and (2) “science- and risk-based approaches” for CMC development that “may be warranted and utilized.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

GeriPal

FEBRUARY 15, 2024

Going into patient’s homes was eye opening. There were trip hazards, loose carpets, some people were hoarders. And yet, after assisting the older adult to their feet, the EMS providers would leave. Their job was done. It’s not surprising that the number of repeat calls for falls is alarmingly high. Alex: I think this is a first.

Community 115

Community Transportation IT PCP 115

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 122

Patient-Centered IT Illness Patients 122

The Clinical Problem Solvers

FEBRUARY 8, 2023

Between 2007 – 2019, Black individuals experienced a higher death rate for opioid overdose deaths than any other racial or ethnic group. These narratives have vilified individuals who would benefit from comprehensive, person-centered substance use treatment, rather than incarceration and other adverse harms.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

GeriPal

JUNE 9, 2022

And palliative care was as a program was just growing at Penn moving from just consult hospice to actually having a team when I was training. How do we move from efficacy (works in highly controlled settings) from effectiveness (works in real world settings? What’s the role of implementation science? What is a pragmatic trial ? Transcript.

Consulting 99

Consulting Patient-Centered Diagnosis Referral 99

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 115

Consulting Patient-Centered IT Patients 115

GeriPal

OCTOBER 26, 2023

Ann: Well, I think teamwork is key in this space and I am a big baseball fan, big Red Sox fan, which is not a good thing to be right now, but I really think it’s indicative of how we should all be working together on this team to help our seriously ill patients. Ann: No, he was very excited. And this time everybody’s joining in.

Patient-Centered 132

Patient-Centered Hospital Patients IT 132

GeriPal

JUNE 5, 2025

So, how can we improve palliative care for individuals in nursing homes? Despite these substantial needs, specialized palliative care beyond hospice is rare in nursing homes. Furthermore, only about half of nursing home residents nearing the end of life receive hospice care. And it’s, I think, a very uplifting song. No problem.

Nurse Practitioner 78

Nurse Practitioner Referral Consulting Board-Certified 78

PEMBlog

MARCH 27, 2024

She did her MD/PhD at Columbia University, where she investigated the diagnostic utility of exome sequencing for kidney disease. Meaning that an individual must inherit two copies of the mutation, so one from each of his or her parents, to be affected. You can contact her via email at egroopman@childrensnational.org.

Consulting 59

Consulting Individual Families Family 59

PEMBlog

JUNE 2, 2025

Evaluation consists of lab studies, including CBC, CMP, BNP, troponin, UA, UDS, TSH with reflex to T4, and urine pregnancy test for individuals with a uterus. Additionally, hydralazine is another agent that was previously utilized in pediatric hypertensive emergencies. 4 mcg/kg/min; onset of action is less than 5 minutes.

Hypertension 75

Hypertension Management Physicals Lab Testing 75

GeriPal

MAY 15, 2025

Prior podcasts on the ethics of nudging , and a different trial conducted by Kate and Scott in which the default for hospitalized seriously ill patients was to receive a palliative care consult. What is sludge? Sludge is apparently when you create barriers or extra work for someone. We’ve done a podcast already on nudging. Where was it?

Patient-Centered 117

Patient-Centered Hospital IT Illness 117

GeriPal

APRIL 14, 2022

So for those of you listening via YouTube, here’s the live version for those of you who are listening on the podcast, you’re going to get my prerecorded version with lots of loops and I’m doing consultation with my new music teacher who’s a music producer in LA. But does this drug really live up to the hype?

Illness 102

Illness Patient-Centered IT Patients 102

GeriPal

APRIL 10, 2025

I think that study was really important, especially I think the message that I give people is you can do something as simple as calling a consultation and improve quality of life months later. I cant do the primary thing Ive been trained to do: ABC, ABC, ABCs. They got training in Vital Talk and ELNEC. They got feedback. So did it matter?

Patient-Centered 77

Patient-Centered IT Hospital Patients 77

GeriPal

FEBRUARY 13, 2025

You did a rural tele-palliative care consultation study. And so the video consult was what became the mode. Marie 03:42 So probably the most important thing is we developed the consultation as a culturally based consultation process. And then we incorporated that information into the consultation process.

Consulting 63

Consulting Community Patient-Centered Families 63

GeriPal

JANUARY 20, 2023

He’s a geriatrician and Chair of Public Policy for the California Association of Long-Term Care Medicine. Welcome back to the GeriPal podcast, Mike. I hope I got that right. Mike: You got it right. Great to be back. Alex: And we have Jasmine Travers who’s joining us from Israel. Jasmine: Yes. Eric: Can I ask why?

Finance 95

Finance Board-Certified IT Provider 95

FDA Law Blog

JULY 9, 2024

Where sponsors plan to conduct several clinical studies that may be subject to DAP requirements, the plan for each study should reflect a strategy that leads to an overall proportionate representation, even though individual studies may not. population demographics. population demographics. by sex, age or by genetic variations).

Clinic 59

Clinic Provider Individual IT 59

GeriPal

MARCH 7, 2024

But before we jump into that topic, John, do you have the song request for Alex? John: I do. It’s Jimmy Buffett’s song, Bubbles Up. It was on his last album. As you may know, Jimmy Buffett passed away in August of a rare skin cancer. When I heard Bubbles Up, I was really struck by two things. How do you see the light? You were a what?

Provider 117

Provider Illness IT Healthcare 117

GeriPal

DECEMBER 19, 2024

So we’re going to be talking about palliative care for individuals with mental illness. We discuss the following: What is Palliative Psychiatry (and how is it different from Palliative Care Psychiatry)? What does it look like to take a palliative approach to severe mental illness? Is “terminal” mental illness a thing?

Illness 101

Illness Mental Health IT Patient-Centered 101

FDA Law Blog

AUGUST 21, 2023

Further, FDA has utilized a variety of strategies to call attention to safety issues through Dear Doctor letters or other forms of communication, even if directing changes to labeling is difficult. Koblitz & Deborah L. Agency officials estimated that it took at least 6 years to complete the required rulemaking process.”

Manufacturing 40

Manufacturing Consulting Healthcare Professional Vaccination 40

New South Family Medicine and MedSpa

SEPTEMBER 17, 2019

However, people need to understand what works best for them individually. Food has the power to regenerate the new you! The world of diets and dietary theories is complicated and can be overwhelming. Eating a diet made of whole foods, and no, not just anything you purchase from the Whole Foods grocery store.

Referral 40

Referral Family Medicine DO Primary Care 40

GeriPal

SEPTEMBER 19, 2024

So, basically, with a stepped care model, the goal is to tailor care delivery to the patient’s needs while at the same time utilizing less clinician resources. Summary Transcript CME Summary If palliative care was a drug, one question we would want to know before prescribing it is what dose we should give. Saw them play a couple times.

Patient-Centered 119

Patient-Centered IT Patients Hospital 119

GeriPal

JULY 20, 2023

Before we do, I think, Joe, you have a song request for Alex. Joe: I do. I would like to hear Space Oddity and it’s because I can’t imagine being more lonely and isolated than being in a tin can orbiting around the earth by myself and just how comforting it is even to hear that scratchy little voice from ground control. Joe: Right.

Telemedicine 73

Telemedicine Telehealth Patient-Centered Board-Certified 73