FDA Law Blog

OCTOBER 13, 2024

Designed to incentivize the development of drugs for pediatric rare diseases where such development may not otherwise have occurred, vouchers may be granted for drugs for serious or life-threatening rare diseases where the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years.

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Government IT Education Individual 64

The Clinical Problem Solvers

DECEMBER 16, 2020

19:05 Clarifying the “ethics vs science” argument and critiquing research techniques 22:00 Resurgence of race-based speculation in COVID-19-related research 25:57 Implantation of ideas about innate racial inferiority within medicine 28:32 Will removal of race from algorithms potentially harm our patients?

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Clinic Education Clinical Practice Patient-Centered 52

FDA Law Blog

SEPTEMBER 6, 2022

This Draft Guidance, when finalized, will replace the Final Guidance issued just six years ago (the 2016 Guidance). Changes from the 2016 Guidance. In these cases, the sponsor can distribute the additional costs to reduce the per patient cost difference between patients treated earlier and patients treated later.

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Clinic Manufacturing Patients IT 52

FDA Law Blog

NOVEMBER 1, 2023

The PR first sets out to establish that it has authority to regulate in vitro diagnostic “test systems” as devices, and not just the system’s individual components, such as reagents, instruments, specimen collection devices, and software.

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Manufacturing Hospital Healthcare Medical 81

FDA Law Blog

OCTOBER 10, 2022

The CDS Guidance interprets the “medical software” carve-out of the 21st Century Cures Act (2016) as it pertains to Clinical Decision Support (CDS) software functions. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information.

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Clinic Medical Provider Patients 52

FDA Law Blog

JANUARY 26, 2022

Component 1 was a disease state component – identified as “The Journey Forward: Ryan Murphy” or “The Journey Forward: Allysa Seely.” (Note that Allysa Seely is a Paralympian gold medal triathlete, and swimmer Ryan Murphy is a 2016 Olympian and gold medalist.)

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IT Education Utilities Patient-Centered 40

FDA Law Blog

MARCH 17, 2022

We blogged on the final 2016 guideline here on March 17, 2016). As explained more fully below, CDC concedes that states, insurers, pharmacies and pharmacy benefit managers have implemented laws, regulations and policies that have misapplied the 2016 guideline. 2016 Guideline. Proposed 2022 CDC Practice Guideline, 7,839.

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Patient-Centered Clinical Practice Patients Individual 75

Physician's Weekly

JUNE 21, 2025

The results showed that 13,780 individuals experienced ischemic stroke, with a crude annual incidence of 30.3 The PFO was identified in 749 patients (5.4%), who were generally younger and had fewer risk factors compared to non-PFO patients (all P value < 0.05). per 1,00,000 inhabitants/year. per 1,00,000 inhabitants/year.

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Diabetes Diagnosis Patients Individual 52

Annals of Family Medicine

NOVEMBER 20, 2024

Objective: Determine the epidemiological trends for patients infected with N. Population Studied – The Vizient® Clinical Data Base was queried for inpatient discharges between January 2016 and February 2024 with an ICD-10-CM diagnosis code for naegleriasis (B60.2). Study Design and Setting: Retrospective case series.

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Diagnosis Patients Clinic Individual 130

FDA Law Blog

NOVEMBER 29, 2022

Houck — On November 4th, CDC issued its revised guideline on prescribing opioids for pain as an expansion and update of its 2016 CDC Opioid Prescribing Guideline. CDC received some 5,500 comments from patients, caregivers, clinicians and interested organizations to the proposed guideline update it issued in February. RR-3):1–95.

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Patients Patient-Centered ER Individual 52

The Clinical Problem Solvers

DECEMBER 20, 2021

Fields Guests: Thu Quach, PhD, and Tung Nguyen, MD Time Stamps 00:00 Introduction 04:00 How Dr. Thu Quach’s and Dr. Tung Nguyen’s journeys shape their work 11:40 Policy work as a way of mitigating burnout 12:55 Balancing individual and communal focus (include?) Remember that more deeply understanding your patients can provide meaning!

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Community Patient-Centered Relationship Healthcare 52

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.

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Community Transportation IT PCP 116

GeriPal

FEBRUARY 29, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. Alex: Okay.

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IT Patient-Centered Illness Education 127

GeriPal

JUNE 30, 2022

You have a patient with dementia severe enough that she cannot recognize relatives. A huge part of this decision rests on (1) her previously stated wishes, values, and goals (prior to the onset of dementia); and (2) the outcomes of surgery for patients with dementia. Summary Transcript Summary. She falls and breaks her hip.

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Patient-Centered Complication Patients IT 101

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. And that’s it. Kate: Sure.

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Consulting Patient-Centered Patients IT 116

GeriPal

DECEMBER 8, 2022

Clinicians “catching” patient life stories. . Our patients aren’t “the 76 year old with heart failure in room 202,” as Heather Coats astutely noted. Storytelling Helps Hospital Staff Discover The Person Within The Patient. She was a heart failure patient. Because that really is what this is about. What’s in a story?

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Patient-Centered Illness Healthcare IT 116

GeriPal

APRIL 14, 2022

Adapting Palliative Care Skills to Provide Substance Use Disorder Treatment to Patients With Serious Illness . So I have thought about this for months, maybe years since your 2016, cycle blog, but we have picked Under Pressure by David Bowie and Queen. Learn about using the low dose buprenorphine patch: . Eric: And why Under Pressure.

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Illness Patient-Centered IT Patients 103

The Clinical Problem Solvers

MAY 30, 2022

We all must recognize the codification of racism within our institutions and work to unlearn these hierarchies in order to better care for Black and Indigenous patients. She urges us to recognize that maternal mortality changes the life trajectories of individuals and communities. Published April 20, 2016. Healthcare.

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Community Patient-Centered Families Family 52

GeriPal

APRIL 3, 2025

Annie 02:31 So if you go to the A G S meeting every year, you know that this group of three individuals comprises the AGS literature update. Annie 05:16 So if you look back in history, I think Eric and Ken have been doing this since 2016. But in spite of that, it is a lot of work for three individuals to pull all this together.

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IT Hospital Screening Patients 65

FDA Law Blog

MAY 5, 2024

Houck — The Associated Press reported on Tuesday following confirmation by five anonymous individuals with knowledge that the Drug Enforcement Administration (“DEA”) is moving to reschedule marijuana from schedule I to the less stringently controlled schedule III. By Larry K. 30, 2024). 53,688 (Aug. 53,767 (Aug.

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Medical Manufacturing Physicals Healthcare Professional 95

GeriPal

DECEMBER 15, 2022

Along the way we address: Is this degree of slowed cognitive decline meaningful to patients or care partners? Eric: So patient narrative storytelling, independent of what we call it, I’d like to turn to both of you and just how you got interested in this as a subject. She was a heart failure patient.

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IT Patient-Centered Healthcare Illness 106

GeriPal

JULY 28, 2022

But at that time I was struck by how in that field, there wasn’t a focus or really interest in symptom management and support for patients and their families. Eric: And what a research agenda that you’ve done, including one of the most seminal papers that we have in palliative care in lung cancer patients.

Illness 111

Illness Hospital Patient-Centered Patients 111

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.

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Patient-Centered IT Hospital Patients 78

PEMBlog

MARCH 27, 2024

She aims to become a physician-scientist in pediatrics and medical genetics, engaging in bench-to-bedside research that utilizes multi-omics-based approaches to provide a molecular diagnosis and support personalized care for individuals with suspected rare genetic diseases and their families. 2016 Jan;37(1):3-15; quiz 16-7, 47.

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Consulting Individual Families Family 59

GeriPal

AUGUST 25, 2022

Second, Hospice was originally designed for patients with advanced cancer, but the fastest growing admitting diagnosis is dementia. Krista Harrison found , to her surprise, that caregivers of people with dementia who died rated hospice as well as similar patients without dementia who died on hospice. AlexSmithMD. Transcript.

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Families Family IT Patients 107

GeriPal

AUGUST 24, 2023

Harvey is probably best known for his work in developing dignity therapy, a psychological intervention designed specifically to address many of the psychological, existential, and spiritual challenges that patients and their families face as death approaches. Just an extraordinary cast of individuals who were really so incredibly inspiring.

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Patient-Centered Patients IT Illness 98

BMJ

FEBRUARY 8, 2021

Besides the risks to an individual, there are also population-level harms from normalizing certain harmful behaviors (e.g., Increased quality of patient-provider communication, including offering behavioral counseling when needed, may avert unnecessary prescriptions. PMID: 20924877; PMCID: PMC2951617. Pediatrics. doi: 10.1542/peds.2019-1372.

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Medical Holistic Care Healthcare Healthcare Professional 40

GeriPal

JANUARY 11, 2024

The number of people who have used MAID in Canada since it was legalized in 2016 has increased year on year from about 1,000 people in the first year to over 13,000 people in 2022. And importantly the patient has to have capacity and they have to be able to take the drug themselves. Four percent. But that was separate from MAID.

Illness 144

Illness IT Medical Provider 144

GeriPal

OCTOBER 5, 2023

I love this article as it specifically discusses what’s wrong with “ need ” statements and how we can shift our communication and thinking to create space for deliberation about patients’ priorities and the best course of action. Now doctors are unwilling to understand patients’ values and make recommendations, taking the science to it.

Illness 136

Illness IT Patient-Centered Families 136

FDA Law Blog

FEBRUARY 9, 2022

DEA regulations state that a pharmacist has a corresponding responsibility not to fill a prescription unless it is issued for a “legitimate medical purpose by an individual practitioner acting in the usual course of [their] professional practice.” 10, 2016); East Main Street Pharmacy; Affirmance of Suspension Order, 75 Fed.

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IT Insurance Government Patients 40

PEMBlog

DECEMBER 14, 2023

Tracheomalacia and bronchomalacia in children: incidence and patient characteristics. 2016 Apr;83:78-83. Well, they could use lasers or cold steel or microdebridement, and it’s really tailored to the individual patient’s anatomy. 2005 Nov;128(5):3391-7. Isaac A, Zhang H, Soon SR, Campbell S, El-Hakim H.

Diagnosis 52

Diagnosis IT Diagnose Patients 52

GeriPal

MARCH 30, 2023

Liz wrote a fabulous perspectives piece in the NEJM titled “ Deciding on My Dimples ” which talks about her experience as a patient doing shared decision making during neurosurgery for resection of an astrocytoma. But my piece in the New England Journal is about being a patient right before awake brain surgery. I could learn this.

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IT Patient-Centered Patients Healthcare 96

Alabama Academy of Family Physicians

FEBRUARY 20, 2025

Since 2016, HPAI H5N1 has been detected in wild birds in the United States during screening efforts by wildlife authorities. There have been a few severe cases and one individual died with H5N1 infection. H5N1 is currently known to be widespread among wild birds and is thought to be spread by migratory waterfowl.

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Patient-Centered Provider Manufacturing Screening 130

BMJ

JUNE 25, 2021

9 The availability of electronic health records makes it easier to follow up on patients’ health information for an extended period. In clinical practice, patients are not fixed on a certain treatment regime and can start and stop at any time. Health Survey for England 2016: Prescribed Medicines.; 2017;390(10100):1345-1422.

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Primary Care Clinical Practice Electronics Clinic 40

GeriPal

JULY 25, 2024

The PPS is one of the most widely used prognostic tools for seriously ill patients, but the prognostic estimates given by the PPS are based on data that is well over a decade old. It is appropriate for all patient populations, and it is developed specifically for the palliative care and hospice populations. Why do this?

Families 108

Families Family Patient-Centered Patients 108

GeriPal

APRIL 20, 2023

Today we talk with Margot Kushel about how we got here, including: That sense of powerlessness as a clinician when you “fix up” a patient in the hospital, only to discharge them to the street knowing things will fall apart. What are the structural factors and individual factors that contribute to homelessness?

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Mental Health IT Community Individual 124

FDA Law Blog

FEBRUARY 11, 2024

There has been no evidence that marijuana’s schedule should change since the last rescheduling review in 2016. Thousands of doctors in the 38 states that permit the medical use of cannabis recommend marijuana to their patients and millions of patients consume medical marijuana under healthcare professionals’ guidance each year.

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Medical Healthcare Professional Community IT 59