FDA Law Blog

APRIL 25, 2023

Congress has given FDA the authority to require device manufacturers to provide cybersecurity information in their premarket submissions for a “cyber device.” A recent amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act) added a new section about cybersecurity for “cyber devices.” Software in a Medical Device, or SiMD).

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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.

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The Clinical Problem Solvers

DECEMBER 16, 2020

Tsai has seen race-based medicine play out in clinical practice 10:45 What role should race play in making clinical decisions? 13:16 Status of the current conversation on removing race from eGFR calculators: why is it so contentious? Poet Marge Piercy has written, “The work of the world is as common as mud.”

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FDA Law Blog

MARCH 6, 2022

Part 820, with a newly named Quality Management System Regulation (QMSR). The QMSR omits many of the specific QSR requirements that currently appear in the regulations, and instead incorporates by reference an international standard for medical device quality management systems.

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FDA Law Blog

FEBRUARY 22, 2023

To justify an expansion of the 510(k) burden of this magnitude, FDA needs to provide a clear and detailed accounting of what the problem is, the cost of this change, and why it will improve safety without hindering the development of better devices. By Jeffrey K. But there is a very big fly in this ointment.

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FDA Law Blog

MAY 31, 2021

Manufacturers provide patient savings programs at the pharmacy counter to defray the patient’s out-of-pocket costs such as co-pays and deductibles. In addition, CMS proposes to extend the effective date of a 2016 regulation that requires AMP and Best Price to include sales to purchasers in the U.S. See our summary at 2-4.

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FDA Law Blog

APRIL 11, 2022

Shapiro — One of the more complex areas of device regulation is the management of risks associated with malfunctions reported from the field. Medtronic Warning Letter) provides an important reminder from FDA as to the correct estimation of risk associated with malfunctions. A December 2021 warning letter to Medtronic, Inc.

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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. 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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FDA Law Blog

APRIL 20, 2021

Remove non-device software functions intended for storing and retrieving, so that a medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. By McKenzie E. Certain types of clinical decision-support software. Medical Image Storage Device.

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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. 7,838 (Feb.

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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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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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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. 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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Physician's Weekly

JUNE 11, 2025

Despite the emphasis on U=U as a key HIV prevention strategy since 2016, none of the included studies explicitly described U=U or U=U messaging as an intervention component,” the researchers wrote. The systematic review of peer-reviewed intervention was published from 2018 to 2023. Of the 669 participants, the mean age from studies was 45.4

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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

GeriPal

APRIL 14, 2022

Adapting Palliative Care Skills to Provide Substance Use Disorder Treatment to Patients With Serious Illness . Management of chronic pain in the elderly: focus on transdermal buprenorphine. 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.

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Illness Patient-Centered IT Patients 102

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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GeriPal

APRIL 3, 2025

We used all of our political capital to make sure it happens in Chicago, which is where we started for the literature Updates back in 2016, back when it was just me and Ken, and then we brought in Alex, like two years later. Annie 05:16 So if you look back in history, I think Eric and Ken have been doing this since 2016. Of course.

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IT Hospital Screening Patients 64

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

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. You get me with one-finger-chords on the guitar if you’re watching on YouTube (best I could manage). Four percent. It is the slippery slope made real.

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Illness IT Medical Provider 144

The Clinical Problem Solvers

MAY 30, 2022

Kozhimannil—the Distinguished McKnight University Professor in the Division of Health Policy and Management at the University of Minnesota and Director of the Rural Health Research Center. 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.

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Community Patient-Centered Families Family 52

FDA Law Blog

MAY 5, 2024

The White House Office of Management and Budget will review the rescheduling proposal. FDA/HHS Analysis, 2023 FDA/HHS last conducted an eight-factor analysis of marijuana in 2016 and concluded that marijuana continued to meet schedule I criteria. 12, 2016); Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed.

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Medical Manufacturing Physicals Healthcare Professional 95

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

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

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. 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. .

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Illness Hospital Patient-Centered Patients 110

FDA Law Blog

FEBRUARY 5, 2024

If expanded choices are desirable, FDA recommends following the standards from the 2011 HHS Implementation Guidance on Data Collection Standards for Race, Ethnicity, Sex, Primary Language, and Disability Status and provides more detailed categories from that guidance. The comment period ends on April 29, 2024.

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GeriPal

JUNE 30, 2022

Should she be treated non-operatively, with aggressive symptom management? Should she have an operation, and risk the pain, potential complications, and attendant delirium associated with the operation? Eric: So we’re going to be talking about dementia and considerations around surgery for individuals with dementia. It was Remember Me.

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Patient-Centered Complication Patients IT 101

PEMBlog

MARCH 27, 2024

This episode will help you better prepare for and manage children with inborn errors of metabolism in the Emergency Department. 2016 Jan;37(1):3-15; quiz 16-7, 47. As always, I’m your host, Brad Sobolewski, and this episode focuses on the management of children with metabolic disorders who present to the emergency department.

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PEMBlog

DECEMBER 14, 2023

Learn all about diagnosis and management of this common problem in this brief podcast episode. 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. 2005 Nov;128(5):3391-7. Isaac A, Zhang H, Soon SR, Campbell S, El-Hakim H.

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Diagnosis IT Diagnose Patients 52

GeriPal

AUGUST 24, 2023

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. You’d imagine that as a seasoned palliative care doc, I’d have a pretty good definition by now of what “maintaining dignity” or “loss of dignity” means, but you’d be sadly wrong. Harvey: I feel welcome.

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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

BMJ

JUNE 25, 2021

This can also be seen in the sequential treatment decisions in managing cardiac risk 3 and the alternating statin therapy usage. This is because clinical trials are expensive to carry out and therefore tend to be of relatively short duration, with statins trials having on average two to five years of treatment exposure. 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.

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Families Family Patient-Centered Patients 106

GeriPal

APRIL 20, 2023

How has the history of redlining and the federal tax subsidy of wealthy (mostly white) people in the form of a mortgage interest deduction contributed to racial inequalities in homelessness? What can we do about it? What are the highest yield interventions and policy changes? What should we call it – homeless or unhoused? Eric: I love this.

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Mental Health IT Community Individual 123

FDA Law Blog

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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Patient-Centered IT Families Family 125

GeriPal

JANUARY 5, 2023

“Typically when we think about conscience in medical ethics we think about it in terms of a negative claim of conscience, where a clinician refuses (or objects) to provide care. Lisa was writing about providing abortion care, but she just as easily could have been writing about providing medical aid in dying in states where it is illegal.

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