FDA Law Blog

NOVEMBER 20, 2024

Since the first issuance of FDA’s guidance Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” in 2016, sponsors submitting premarket submissions to FDA have had the option of using these techniques to evaluate certain biocompatibility endpoints.

Provider 59

Provider Medical Manufacturing Consulting 59

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!)

IT 105

IT Patient-Centered Healthcare Illness 105

Permanente Medicine

APRIL 29, 2025

From 2012 to 2016, death rates from colorectal cancer among Black people were nearly 40% higher than in whites and double that seen in Asians and Pacific Islanders, according to the American Cancer Society. The electronic health record system automatically prompts care teams to schedule patients for health screenings.

Screening 52

Screening Checkup Integrated Care Electronics 52

The Motivated MD

SEPTEMBER 19, 2024

A study by Johns Hopkins in 2016 found that medical errors may potentially be the third leading cause of death nationwide. Before we discuss each individual savings account, let us first highlight exactly what it means to ‘automate’ your savings. So yes, humans make mistakes. This is the same for personal finances.

Finance 52

Finance Individual Education Healthcare Professional 52

GeriPal

FEBRUARY 29, 2024

The hot sauces progressed from mild to extreme (and I mean extreme) heat. Can I just say…it works? Being asked a question with your mouth on fire, sweat streaming down your face, feeling the most awake and terrified you have ever been in your life, forces you to give an unadorned answer, straight from the heart. Lynn: Okay. Anne: GeriPal edition.

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IT Patient-Centered Illness Education 126

The Clinical Problem Solvers

DECEMBER 20, 2021

difficulty of sending patient messages through the electronic medical record in languages other than English), limited healthcare literacy, and English-only signage on healthcare campuses are just a few of the structurally racist barriers faced by many Asian folks seeking healthcare. Insufficient language services (i.e.,

Community 52

Community Patient-Centered Relationship Healthcare 52

GeriPal

DECEMBER 8, 2022

Integration of Person-Centered Narratives Into the Electronic Health Record: Study Protocol. Connection — The Integration of a Person-Centered Narrative Intervention into the Electronic Health Record : An implementation study. Summary Transcript Summary. Narrative medicine? Because that really is what this is about.

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Patient-Centered Illness Healthcare IT 115

GeriPal

MARCH 28, 2024

Kate: So it was an embedded alert in the electronic health record and they just clicked those two answers very quickly. I’m just stunned even writing that! We’ve come so far as a field. This is Eric Widera. Alex: This is Alex Smith. Eric: Alex, who do we have with us today? Were you at the GeriPal pub crawl? laughter] Eric: 2:30 AM.

Consulting 115

Consulting Patient-Centered IT Patients 115

FDA Law Blog

DECEMBER 18, 2022

Then, in 2016, FDA noted its goal to streamline MDR requirements in the Medical Device User Fee Amendments of 2017 (MDUFA IV) commitment letter. Summary malfunction reports should be submitted electronically on Form FDA 3500A. FDA began an initial VMSR pilot program in 2015. July 1 – September 30. October 31. October 1 – December 31.

Medical 59

Medical Manufacturing Individual Provider 59

GeriPal

APRIL 10, 2025

I think back in what, May 2016, you published a randomized controlled trial, first author, palliative care and the ED randomized study, cancer patients. Eric 04:26 So that 2016 study was in the ED, but it was getting specialty palliative care to see them when they were hospitalized, is that right? They got feedback. So did it matter?

Patient-Centered 77

Patient-Centered IT Hospital Patients 77

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

GeriPal

JUNE 30, 2022

Eric: So we’re going to be talking about dementia and considerations around surgery for individuals with dementia. 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. Joel: Yeah, right, I Will Remember You, right. Alex: … Sarah McLachlan.

Patient-Centered 101

Patient-Centered Complication Patients IT 101

PEMBlog

MARCH 27, 2024

2016 Jan;37(1):3-15; quiz 16-7, 47. This episode will help you better prepare for and manage children with inborn errors of metabolism in the Emergency Department. Consider it a supplement to what you remember from Biochemistry and the instructions on the family’s laminated care plan sheet. In: StatPearls [Internet]. Pediatr Rev.

Consulting 59

Consulting Individual Families Family 59

FDA Law Blog

MAY 21, 2024

We wondered how given that HHS and the Drug Enforcement Administration (“DEA”) conducted eight-factor scheduling analyses in 2016, concluding that there was “no substantial evidence that marijuana should be removed from Schedule I.” 12, 2016) ; Denial of Petition to Initiate Proceedings to reschedule Marijuana, 81 Fed. 12, 2016).

Physicals 69

Physicals Medical Clinic Emergency Room 69

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. This information might be available in electronic health records, however it is extremely labour intensive to pull out the information when having a large sample size, in our case over 110 000 patients.

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Primary Care Clinical Practice Electronics Clinic 40

Physicians News Digest

APRIL 3, 2025

Makary published a controversial study in 2016 hypothesizing that errors killed 250,000 people a year in the U.S. Singh devises ways to integrate technologies like telemedicine and artificial intelligence into electronic health records to alert doctors to potential prescribing errors or misdiagnoses. million, he said.

Patient-Centered 52

Patient-Centered Hospital Diagnose Medical 52