FDA Law Blog

AUGUST 11, 2024

on July 17, 2024 for a social media post published by Instagram influencer Brittany Mahomes (who has 2 million Instagram followers) about AUVI-Q (epinephrine injection, USP) that “entirely omit[ed] all risk information” about the drug. August 2024 Untitled Letter to Mirati Therapeutics Inc.

Clinic 59

Clinic Provider IT Complication 59

PEMBlog

OCTOBER 18, 2024

The condition affects multiple organ systems—muscular, cardiac, and respiratory—leading to a myriad of clinical complications. Once patients become non-ambulatory, they often develop secondary complications like lymphedema, which further complicates their care. Treasure Island (FL): StatPearls Publishing; 2024 Jan-.

Patients 52

Patients Complication Management Consulting 52

FDA Law Blog

FEBRUARY 29, 2024

A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. Drug companies are still required to conduct studies to confirm the anticipated clinical benefit. That did not happen.

Clinic 59

Clinic IT Provider Patient-Centered 59

GeriPal

JANUARY 23, 2025

Join us as we dive deeper into these studies and discuss the implications for clinical practice and patient care. And there’s so much work on, you know, you’ve got to take these medicines, you got to prevent this treat, that there isn’t that same sort of clinical momentum towards deprescribing. Ethical and practical.

Specialization 120

Specialization IT Patient-Centered Medical 120

GeriPal

JUNE 20, 2024

ABIM MOC credit will be offered to subscribers in November, 2024. George 03:01 So I would say that as many clinical issues in older adults, we need to think about them in two ways. And we can talk about that later in terms of potential clinical implications that may have code. Eric 11:57 In, let’s say, my clinic.

IT 121

IT Patient-Centered Patients Clinic 121

Aspiring Minority Doctor

DECEMBER 31, 2024

So with that being said, and today being New Year’s Eve, I'm going to use this post to give a recap of 2024 :) January During my last post, I was in Orlando, Florida completing my pediatric craniofacial and plastic surgery months. I think that pretty much sums up 2024! I was so happy to finally see it come to fruition.

Medical Student 52

Medical Student IT Patient-Centered Medical 52

Medical Xpress

JUNE 16, 2025

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. 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.

Mental Health 52

Mental Health IT Medical Specialization 52

Medical Xpress

JUNE 16, 2025

But what we observed was much more complicated." The traditional model is simple: SCN neurons were believed to act like runners in a relay race, passing the light signal along in a linear chain. Some SCN neurons were activated by light, while others were inhibited.

Provider 109

Provider Medical Complication Diabetes 109

PEMBlog

JUNE 2, 2025

Clinical Case You are a senior resident working in the busy emergency department on an overnight shift. Hypertensive emergency is a clinical diagnosis characterized by a sudden and severe elevation in blood pressure accompanied by signs of acute end-organ dysfunction. Look for the underlying cause renal disease leads the list in kids.

Hypertension 75

Hypertension Management Physicals Lab Testing 75

GeriPal

JANUARY 25, 2024

ABIM MOC credit will be offered to subscribers in November, 2024. David: Similarly informed by my clinical experience, really, actually, beginning in residency when I took care of a lot of sick folks in the hospital, particularly those with cancer and heart and lung diseases like these. It used to be a much more complicated model.

Patient-Centered 123

Patient-Centered IT Illness Patients 123

GeriPal

JULY 11, 2024

ABIM MOC credit will be offered to subscribers in November, 2024. Can you come and be in our clinic once a week? It used to also be a social worker and myself who would actually go to clinic and spend some time up there. I started our liver embedded liver clinic about seven and a half years ago.

Patient-Centered 110

Patient-Centered IT Patients Clinic 110

GeriPal

JUNE 27, 2024

ABIM MOC credit will be offered to subscribers in November, 2024. The question I would ask is, how helpful is that in our clinical practice? So we put those cutoffs, and I asked the question earlier, how helpful are those cutoffs in clinical practice? For any MOC questions, please email moc@ucsf.edu. And so bathe is an acronym.

Illness 130

Illness IT Diagnosis Patient-Centered 130

PEMBlog

JANUARY 16, 2025

Well dive into the clinical presentations, including acute and chronic symptoms, the dangers of sudden sniffing death, and the specific risks associated with nitrites, hydrocarbons, and nitrous oxide. Updated February 26, 2024. Further complicating matters is that each inhalant has its own special risks. Ganetsky M (ed).

Complication 52

Complication Patient-Centered Management Patients 52

GeriPal

NOVEMBER 7, 2024

About half of patients who are over the age of 65 start dialysis with a GFR of over 9, which is sort of the level below which we have clinical trial evidence for suggesting that there may not be a benefit to starting at that level of GFR. Clinical experience. Maria 29:14 We’ll be more statistical than clinical, I think.

Management 117

Management Patient-Centered Patients IT 117

GeriPal

NOVEMBER 21, 2024

The clinical trials and the this and that. And she says, no, I heard that there’s a clinical trial at the Mayo Clinic, and I’m wondering about this. And that’s why there’s a ton of laughter in my clinic, really. This is so complicated. To get even more complicated. They know which.

Illness 126

Illness IT Patient-Centered Patients 126

GeriPal

FEBRUARY 15, 2024

ABIM MOC credit will be offered to subscribers in November, 2024. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. Subscribers will claim MOC credit by completing an evaluation with self-reflection questions.

Community 116

Community Transportation IT PCP 116

GeriPal

JANUARY 11, 2024

A planned expansion of MAID to include people with mental illness was placed on hold until March 2024. ABIM MOC credit will be offered to subscribers in November, 2024. Alex: We’re delighted to welcome Leonie Herx, who’s a palliative care physician and clinical professor at the University of Calgary. Bill: Thank you.

Illness 144

Illness IT Medical Provider 144

GeriPal

FEBRUARY 8, 2024

ABIM MOC credit will be offered to subscribers in November, 2024. She softened to her suffering, and she trusted me enough to have a moment, that she could look into that and see that, yes, she had her clinical judgment, which was fine, but also that there was another processes going on, which was her own suffering.

IT 137

IT Families Family Physicals 137

GeriPal

JUNE 13, 2024

ABIM MOC credit will be offered to subscribers in November, 2024. How should I define cachexia and anorexia when I’m talking to fellow students or thinking about it in my own clinical practice? I am very much into the fact that when you are really hypogonadic, clinically hypogonadic, I try to prescribe testosterone.

Illness 134

Illness Patient-Centered Patients IT 134

FDA Law Blog

MAY 21, 2024

On Thursday, May 16, 2024 , the Attorney General issued a Notice of Proposed Rulemaking (“NPRM”) to initiate rulemaking proceedings to reschedule marijuana. The NPRM was signed by the Attorney General but published by DEA in the Federal Register on May 21, 2024. 44,597 (May 21, 2024). 21 U.S.C. § NPRM at 44,607. NPRM at 44,617.

Physicals 69

Physicals Medical Clinic Emergency Room 69

GeriPal

MARCH 27, 2025

Summary Transcript CME Summary A pragmatic trial evaluates the effectiveness of a treatment or intervention in real-world clinical practice. And interesting enough, this is a really fascinating study that just got published in JAMA I M in December of 2024. We did it by the clinic level. Alex 03:54 Very generous. Is that right?

Primary Care 80

Primary Care IT Clinic Patient-Centered 80

GeriPal

JULY 25, 2024

ABIM MOC credit will be offered to subscribers in November, 2024. Eric 04:39 Yeah, I see it used on inpatient, side on consult clinics in hospices. Eric 07:03 And those classic studies, were those done in the hospital and PALP care units and clinic? For any MOC questions, please email moc@ucsf.edu.

Families 108

Families Family Patient-Centered Patients 108

GeriPal

SEPTEMBER 14, 2023

That’s focused on older adults who are too frail to get into clinic. In that clinical experience, we saw a lot of older adults who would develop acute illness, often exacerbations of their chronic conditions. We relied on our clinical experience as geriatricians, that home-based primary care experience. Bruce: Sure.

Hospital 115

Hospital Patient-Centered Supply Chain IT 115

PEMBlog

DECEMBER 4, 2024

We will review the clinical presentation, diagnostic strategies, management protocols, infection control practices, and vaccination updates. Learning Objectives Understand the clinical progression of pertussis through its three distinct stages and identify key symptoms, including age-specific presentations in infants and older children.

IT 52

IT Vaccination Diagnosis Complication 52