FDA Law

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This Draft Guidance, when finalized, will replace the Final Guidance issued just six years ago (the 2016 Guidance).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. What’s new in the new Draft Guidance? Not all that much. The new Q & As (Q21, Q22, and Q23) all concern charging in the context of expanded access.

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Clinic Manufacturing Patients IT 52

FDA Law

JANUARY 26, 2022

Note that Allysa Seely is a Paralympian gold medal triathlete, and swimmer Ryan Murphy is a 2016 Olympian and gold medalist.) In defending the complete broadcast, Lilly called out similar elements from each of the individual components as demonstrating its intent to have all three viewed sequentially.

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IT Education Utilities Patient-Centered 40

FDA Law

JUNE 29, 2022

The Expedited Programs Guidance describes situations warranting rescission as when emerging data no longer support the BTD, another product gains traditional approval and evidence is not provided that the designated drug may demonstrate substantial approval over the approved product, or when the program is no longer being pursued.

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IT Clinic Provider Medical 52

FDA Law

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. The guidance provides no rationale for hinging the device status of CDS software on the frequency with which medical information is collected.

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Clinic Medical Provider Patients 52

FDA Law

JUNE 23, 2021

For example, we know that cancer patients have a high tolerance for toxicity when offered a chance at improved survival, a risk tolerance that would not be shared by individuals suffering from the common cold. the morbidity, oftentimes irreversible and progressive, and morality associated with their condition).

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Patients Patient-Centered Clinic Community 52

FDA Law

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

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.

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Finance Individual Education Healthcare Professional 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. And yet, after assisting the older adult to their feet, the EMS providers would leave. Going into patient’s homes was eye opening. Their job was done.

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GeriPal

DECEMBER 15, 2022

Summary Transcript Summary. We’ve talked at length on prior podcasts about the failures of aducnumab, Biogen, and the FDA’s decision to approve it. . But wait, there’s a shiny new anti-amyloid drug, lecanemab! (No No it’s not just the French version of Aducanumab). . In an article in the NEJM (a published article this time, wonder of wonders!)

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IT Patient-Centered Healthcare Illness 105

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

FDA Law

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. We blogged on the 2016 guideline here in March 2016, and the proposed guideline here on March 18th). By Larry K. Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R.,

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Patients Patient-Centered ER Individual 52

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. Lynn: Okay.

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IT Patient-Centered Illness Education 126

FDA Law

DECEMBER 18, 2022

Generally, FDA’s MDR regulations require device manufacturers to submit Medical Device Reports (MDRs) for individual reportable malfunctions within 30 calendar days of the manufacturer becoming aware of the malfunction. The draft guidance provides instructions for completion of this form, including an appendix with a sample report.

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Medical Manufacturing Individual Provider 59

GeriPal

DECEMBER 8, 2022

Summary Transcript Summary. Eric and I weren’t sure what to call this podcast – storytelling and medicine? Narrative medicine? We discussed it with today’s guests Heather Coats, palliative care NP-scientist, and Thor Ringler, poet. It wasn’t until the end that the best term emerged – storycatching. It’s since spread to over 70 VAs.

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Patient-Centered Illness Healthcare IT 115

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. Eric 02:26 We found him in the hallway back there [laughter]. So this is something. Of course.

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IT Hospital Screening Patients 64

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. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

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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. It’s been around for a long time but is acting like the hot new kid in town.

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Illness Patient-Centered IT Patients 102

BMJ

FEBRUARY 8, 2021

The proximity to campus health clinics may also afford college students greater accessibility to healthcare providers for prescription medications such as stimulants which could end up being misused. Besides the risks to an individual, there are also population-level harms from normalizing certain harmful behaviors (e.g.,

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Medical Holistic Care Healthcare Healthcare Professional 40

The Clinical Problem Solvers

MAY 30, 2022

As healthcare providers, we must listen to our patients and use the power of our presence to see birthing people’s full humanity and empowerment. She urges us to recognize that maternal mortality changes the life trajectories of individuals and communities. Published April 20, 2016. Healthcare. 2020;8(1):100367. link] Norris L.

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Community Patient-Centered Families Family 52

GeriPal

JUNE 30, 2022

Eric: So we’re going to be talking about dementia and considerations around surgery for individuals with dementia. Samir: Thanks, Alex and Eric. Before we go into this topic, who has a song request for Alex? It was Remember Me. Was that the title? Alex: I think it’s I Will Remember You. Alex: By … Joel: Sarah McLachlan.

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Patient-Centered Complication Patients IT 101

FDA Law

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. 29, 2023). Letter to U.S. 21 U.S.C. § 812(b)(1). 53,688 (Aug.

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Medical Manufacturing Physicals Healthcare Professional 95

GeriPal

MARCH 28, 2024

Kate: The problem is we communicate late, we share prognosis late, we elicit goals and values late, so all the time while they’re in the ICU getting prolonged intensive care, we don’t really know that we’re providing goal concordant care, so we wanted to nudge it a little upstream. I’m just stunned even writing that!

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Consulting Patient-Centered IT Patients 115

GeriPal

APRIL 10, 2025

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. I think back in what, May 2016, you published a randomized controlled trial, first author, palliative care and the ED randomized study, cancer patients. They got feedback. Eric 01:35 Okay.

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Patient-Centered IT Hospital Patients 77

GeriPal

OCTOBER 5, 2023

Summary Transcript Summary Communicating about a serious illness is hard. Last week’s podcast we talked about the challenge around miscommunication in serious illness. This week we dive into the challenges with communication when it comes to life sustaining treatments and CPR. Welcome to the GeriPal podcast. Jacky: Thank you. It’s a pleasure.

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Illness IT Patient-Centered Families 136

GeriPal

AUGUST 25, 2022

Eric: We have a smorgasbord, if you will, of papers that got published recently around hospice, and that’s why we’re calling it a hospice super special. We’re going to be talking about each one of these papers. But before we do, I think somebody has a song request. Is it you, Melissa? Melissa: It’s me. Yes, it is. Here we go.

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Families Family IT Patients 106

FDA Law

JUNE 24, 2021

In 2016, FDA opened a docket seeking comments on “service, maintenance, refurbishment, and alteration of medical devices” by third parties (see our blog post here ). In an appendix to the draft guidance, FDA provides some helpful examples of the type of information that should be included in such an internal memo.

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Manufacturing Medical Provider IT 52

GeriPal

AUGUST 24, 2023

Just an extraordinary cast of individuals who were really so incredibly inspiring. Summary Transcript Summary I hear the word dignity used a lot in the medical setting, but I’m never sure what people mean when they use it. We talk with Harvey about how he defines “dignity” and how we can understand what it means to our patients.

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Patient-Centered Patients IT Illness 98

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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GeriPal

JULY 28, 2022

Jennifer’s study is most widely known for the “kicker” – not only did it improve quality of life, palliative care was associated with a couple months longer survival. . Areej’s study is remarkably novel in that it is, to our knowledge, the first study of palliative care during curative treatment. . Alex: (singing). Areej: Wow.

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Illness Hospital Patient-Centered Patients 110

PEMBlog

DECEMBER 14, 2023

2016 Apr;83:78-83. Laryngomalacia, is the most common cause of infant stridor. Early diagnosis is crucial as it can impact a child’s growth and development. Most infants get better on their own, but those with severe symptoms need surgical interventions like supraglottoplasty. 2005 Nov;128(5):3391-7. Int J Pediatr Otorhinolaryngol.

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Diagnosis IT Diagnose Patients 52

GeriPal

MARCH 30, 2023

This week we’ve invited three guests to share their stories about storytelling that’s written for healthcare providers. Summary Transcript Summary Two weeks ago on the GeriPal podcast we talked about why and how to write for the general public. The first guest is Liz Salmi. Liz: That’s right. Eric: Why’d you pick this song?

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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. Also, CDC has provided a candidate vaccine virus to manufacturers for rapid production if needed.

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BMJ

JUNE 25, 2021

With landmark analysis, survival can be visualised by plotting the Kaplan-Meier survival curves for the risk groups of interest to provide information about the absolute and relative risks, whereas this is not straightforward for time-dependent Cox regression. Health Survey for England 2016: Prescribed Medicines.; 16 Figure 1.

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Primary Care Clinical Practice Electronics Clinic 40

GeriPal

JULY 25, 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. You got it.

Families 106

Families Family Patient-Centered Patients 106

GeriPal

APRIL 20, 2023

What are the structural factors and individual factors that contribute to homelessness? To what extent is the rise of tech in San Francisco to blame for our local rise in homelessness? What can we do about it? What are the highest yield interventions and policy changes? What are the highest yield interventions and policy changes?

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Mental Health IT Community Individual 123

FDA Law

FEBRUARY 11, 2024

The three letters together provide the range of actions DEA may take: no rescheduling from schedule I (former drug officials), rescheduling to schedule III (Democratic state attorneys general), or descheduling altogether (Democratic senators). Letter 1 is signed by former DEA administrators and Directors of National Drug Policy.

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Medical Healthcare Professional Community IT 59

GeriPal

DECEMBER 21, 2023

Don’t get me wrong, the evidence points to cost savings, but as Chris Callahan and Kathleen Unroe pointed out in a JAGS editorial in 2020 “in comprehensive dementia care models, savings may accrue to Medicare, but the expenses accrue to a fluid and unstable network of local service providers, patients, and their families.” Malaz: I love it.

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