FDA Law Blog

JUNE 27, 2024

Prescribing Red Flags In the Gulf Med decision, DEA emphasized that “[r]ed flags are circumstances surrounding a prescription that cause a pharmacist to take pause, including signs of diversion or the potential for patient harm.” The expert specifically found that: Patient A.R. The expert specifically found that: Patient A.R.

Insurance 52

Insurance Patients Utilities Chronic Condition 52

GeriPal

MAY 5, 2022

We talk with Nick and Meg about: Why hearing loss is important not just in geriatrics but also for those caring for seriously ill individuals. Communication techniques we can use when talking to individuals with hearing loss. Association of Sensory and Cognitive Impairment With Healthcare Utilization and Cost in Older Adults.

IT 102

IT Screening Hospital Clinic 102

FDA Law Blog

APRIL 23, 2023

This Draft Guidance focuses on the use of patient-level data from other clinical trials or from RWD sources. The goal is to select similar patients in the treatment and external control groups. The Draft Guidance also states that sponsors must include in their marketing applications relevant patient-level data for both arms.

Patient-Centered 49

Patient-Centered Clinic Patients Provider 49

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.

Manufacturing 45

Manufacturing Provider Consulting IT 45

FDA Law Blog

SEPTEMBER 20, 2021

From new initiatives to facilitate faster reviews for new indications under the Split Real Time Application Review (STAR) pilot program, to bringing new meetings under PDUFA goals, to continued support for rare diseases and incorporation of the patient voice, the goals letter revealed a good number of welcome announcements.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

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

JANUARY 25, 2024

He also found gaps, including very few studies of patients with lung disease, and little impact of trials on quality of life. Your research is a lot in this patient population, right? However, its main predictors are age, comorbidity, and healthcare utilization. Big randomized control study that came out. Important implications.

Patient-Centered 122

Patient-Centered IT Illness Patients 122

GeriPal

FEBRUARY 15, 2024

The insight started when Carmen, an orthopedic surgeon-researcher, and Katie, a physical therapist- researcher participated in ride-alongs with EMS providers to patient’s homes. Going into patient’s homes was eye opening. It was eyeopening to see patients in their own home. And so that really triggered my interest.

Community 114

Community Transportation IT PCP 114

GeriPal

MARCH 28, 2024

What we did was ask clinicians earlier in the ICU stay for very sick patients to document prognosis, and for those who they thought would survive, to document six-month functional prognosis. Eric: And who are the patients including in this trial, again? Kate: These are very sick patients. I’m just stunned even writing that!

Consulting 115

Consulting Patient-Centered IT Patients 115

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. I have never myself called a palliative care consult as a trainee because we didn’t have one. And I practiced both on the palliative care consult team and in the ICU.

Consulting 99

Consulting Patient-Centered Diagnosis IT 99

PEMBlog

JUNE 2, 2025

Upon entering the room, you find the patients nurse at the bedside already in mid-conversation with the patients parent. In pediatric patients, this condition should be considered when blood pressure exceeds the 95th percentile for age, height, and sex by more than 30 mm Hg, or reaches levels above 180/120 mm Hg in older adolescents.

Hypertension 75

Hypertension Management Physicals Lab Testing 75

GeriPal

OCTOBER 26, 2023

Within hours of recording this podcast, I joined a family meeting of an older patient who had multiple medical problems including cancer, and a slow but inexorable decline in function, weight, and cognition. The patient’s capacity to make decisions was marginal, and his sons were shouldering much of the responsibility.

Patient-Centered 132

Patient-Centered Hospital Patients IT 132

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

GeriPal

JUNE 5, 2025

So, how can we improve palliative care for individuals in nursing homes? Eric 03:25 So we have a lot to talk about, but I’m wondering if we can kind of take a big step back and just talk about the patient population that’s in nursing homes. And so we do have consultants who come in the building. Thank you so much.

Referral 78

Referral Nurse Practitioner Consulting Board-Certified 78

GeriPal

APRIL 14, 2022

Adapting Palliative Care Skills to Provide Substance Use Disorder Treatment to Patients With Serious Illness . And if you want to learn more about buprenorphine from these amazing palliative care clinicians and others, check out of some of these articles: Learn more about caring for those with substance use disorder: . So here we go.

Illness 102

Illness Patient-Centered IT Patients 102

GeriPal

APRIL 10, 2025

I asked emergency medicine clinicians what they thought when a patient who is seriously ill and DNR comes to the ED, and some responded, (paraphrasing), what are they doing here? 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.

Patient-Centered 77

Patient-Centered IT Hospital Patients 77

GeriPal

FEBRUARY 13, 2025

How to be sensitive to the risks of stereotyping based on recommendations from the few members of the board to the many heterogeneous patients served? You did a rural tele-palliative care consultation study. And so the video consult was what became the mode. NCP guideline, standard consultation. Three different articles.

Consulting 63

Consulting Community Patient-Centered Family 63

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. Kate 06:44 Patients were willing to complete advanced directive and picked the middle one. What is sludge? Where was it?

Patient-Centered 116

Patient-Centered Hospital IT Illness 116

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. by sex, age or by genetic variations). socio-economic status, geographic location, comorbidities).

Clinic 59

Clinic Provider Individual IT 59

GeriPal

DECEMBER 19, 2024

A NY Times article titled Should Patients Be Allowed to Die From Anorexia ? So we’re going to be talking about palliative care for individuals with mental illness. That’s how do we treat the mental health needs of patients with serious medical illness? Oh, yeah, yeah. Good artist. Really tasteful.

Illness 101

Illness Mental Health IT Patient-Centered 101

GeriPal

MARCH 7, 2024

Whenever I take care of a patient, I see myself as a family practice doctor, but I’ve been a hospitalist, I’ve been a primary care doctor, and I’ve done palliative. But in the end, I see these as my patients and I’m trying to define what is the right model. I often say that doulas are mirrors. It just depends.

Provider 117

Provider Illness IT Healthcare 117

FDA Law Blog

AUGUST 21, 2023

After all, the labeling is intended to do exactly that: it informs patients and prescribers of the risks to ensure the product is used effectively and in a manner that mitigates risks, according to FDA’s understanding of the relevant science. A recent state law failure-to-warn case in the SDNY makes that very point.

Manufacturing 40

Manufacturing Consulting Healthcare Professional IT 40

GeriPal

JANUARY 20, 2023

I know you’ve been a strong advocate for nursing home patients particularly in California. Eric: Yeah, I guess in the very beginning of the COVID pandemic really highlighting the structural issues, lack of PPE, really people ignoring it outside of just the place to send COVID patients to. It’s been such a challenge.

Finance 95

Finance Board-Certified IT Provider 95

GeriPal

SEPTEMBER 19, 2024

Give too much, it may cause harm (even if the higher dose had no significant side effects, it would require patients to take a lot of unnecessary additional pills as well as increase the cost.) So, what is the effective dose of palliative care? Give too little – it may not work. Jennifer 04:25 I can take that on. Eric 05:32 Yeah.

Patient-Centered 119

Patient-Centered IT Patients Hospital 119

GeriPal

JULY 20, 2023

Clinicians could care for patients across state lines, could prescribe opioids without in person visits, could bill at higher rates for telemedicine than previous to the pandemic. Many patients benefited, not only those isolating due to covid, but also patients in rural areas, patients who are homebound, and many others.

Telemedicine 73

Telemedicine Telehealth Patient-Centered Board-Certified 73