FDA Law Blog

OCTOBER 16, 2023

Lloyd Minor, Dean of the Stanford University School of Medicine discusses both the potential promise of increasing use of AI in healthcare settings (e.g., Just a day earlier, FDA’s Center for Devices and Radiological Health (CDRH) released a list of the guidance documents the Center intends to publish in the upcoming 2024 fiscal year.

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The Clinical Problem Solvers

SEPTEMBER 19, 2024

Describe the positive impacts of qualitative methods on healthcare provision and/or policies in clinical settings. She has advanced training in Quality Improvement and Patient Safety Science. She has advanced training in Quality Improvement and Patient Safety Science. During this episode, we hear from Dr. S.

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Today's Hospitalist

MAY 9, 2025

For many of us, the emergence of medical scribes, both in-person and remote, provided a valuable solution, offloading documentation and allowing us to have more focused patient interactions. It can differentiate between a physician’s questions and a patient’s responses and even filter out non-relevant small talk.

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Myriad Genetics

APRIL 15, 2024

4 In a recent presentation, Dale Muzzey, PhD, Chief Scientific Officer at Myriad, summarized the findings this way: “We followed up with providers regarding their patients who screened positive for 22q. 5 Clear Benefits for Healthcare Providers and Patients The benefits to a high PPV are, well, myriad. We observed 100% PPV.

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FDA Law Blog

DECEMBER 4, 2023

District Court for the Western District of Texas imposed a $275,000 civil penalty on Zarzamora Healthcare LLC, in San Antonio, and its pharmacist-owner. 11, 2023 ( DOJ Press Release ). 6, 2023 ( DOJ Press Release ). Several weeks later, also based on ability to pay, the U.S. 21 U.S.C. § 829; 21 C.F.R. Holiday CVS, 77 Fed.

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The Clinical Problem Solvers

APRIL 3, 2023

[link] CPSolvers: Anti-Racism in Medicine Series Episode 20 – Medical Racism and Indigenous Peoples Show Notes by Sudarshan (“Sud”) Krishnamurthy April 4, 2023 Summary: This episode highlights the checkered past of medicine and the advancements in the field that have occurred at the expense of the humanity of Indigenous peoples.

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PEMBlog

JUNE 14, 2023

This episode is a co-production of the Emergency Medical Services for Children Innovation and Improvement Center whose mission is to minimize morbidity and mortality of acutely ill and injured children across the emergency continuum. It is also the final episode in a 5 episode series focused on agitation in children and adolescents.

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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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FDA Law Blog

AUGUST 7, 2023

By Véronique Li, Senior Medical Device Regulation Expert — The Center for Devices and Radiological Health (CDRH) offers learning opportunities for new and experienced CDRH staff through the Experiential Learning Program (ELP). Submit proposal documents by email to ELP Proposal Submissions by September 5, 2023 at 12 PM ET.

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FDA Law Blog

AUGUST 23, 2023

A DHT is considered “a system that uses computing platforms, connectivity, software, and sensors for healthcare and related uses.” By the end of Q2 FY 2023, FDA will establish a committee including members from CDER and CBER to support implementation of the commitments in this section.

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FDA Law Blog

JANUARY 5, 2023

To date, regulatory enforcement litigation focused on actual or imminent patient harm has taken a backseat to cybersecurity as FDA continues to update and implement its oversight framework. Combination products might be part drug, part device, or part software or hardware.

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GeriPal

NOVEMBER 9, 2023

Hot off the presses RCT in JAMA October 2023: Study that looks at 1000 female resident physicians at 26 sites that showed that coaching improved each outcome assessed (burnout, moral injury, imposter syndrome, self-compassion, and flourishing). [link] 2. Summary Transcript Summary Coaching is in. We address: What is coaching? AlexSmithMD 1.

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FDA Law Blog

OCTOBER 6, 2023

The brevity of this change belies the foreseeably seismic impact of FDA regulation of clinical laboratories on the healthcare system. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. direct-to-consumer tests, tests for use in a public health emergency).

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Common Sense Family Doctor

FEBRUARY 1, 2025

Since the turn of the century, the rise of hospitalists and the corresponding decline in the number of office-based family physicians who provide inpatient care for their own patients has magnified the value of optimizing the handoff from hospital-based teams to primary care physicians.

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The Clinical Problem Solvers

MARCH 4, 2024

During this episode, we hear from Zahra Khan, an educator and editor who has written extensively on abolition in medicine, and Dr. Sayantani DasGupta, a physician-educator, prolific children’s book author and faculty at the Center for the Study of Ethnicity and Race and the Institute for Comparative Literature and Society at Columbia University.

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GeriPal

JANUARY 16, 2025

So I think the first reason that we saw and felt the opportunity was ripe for updating was that some of us had come across some anecdotal examples of patients expressing some offense to that terminology. And I was asking this patient about if he had filled out an advanced directive. Can you guys do that one? Eric 02:39 Absolutely.

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GeriPal

MAY 8, 2025

Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution. It’s there.

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GeriPal

FEBRUARY 8, 2024

2023 Dec 20:S1524-9042(23)00202-3. Our guests are BJ Miller, palliative care physician and c-founder of Mettle Health , and Naomi Saks, chaplain at UCSF. Hospital Chaplains, Spirituality, and Pain Management: A Qualitative Study. Pain Manag Nurs. doi: 10.1016/j.pmn.2023.11.004. 2023.11.004. Epub ahead of print. PMID: 38129210. Kleinman, A.

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GeriPal

NOVEMBER 2, 2023

I’ve seen this question come up a lot since finishing fellowship nearly two decades ago. Historically, answers generally lamented the ever increasing need for geriatrics without a corresponding growth in the number of specialists in the field. Mike, welcome to GeriPal. Mike: Great to be here. Alex: We’ll take any Warriors we can get.

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GeriPal

AUGUST 17, 2023

The outlook on amyloid antibodies are looking brighter though in 2023. However, as noted in our editorial published with the donanemab trial , the modest benefits of amyloid antibodies would likely not be questioned by patients, clinicians, or payers if amyloid antibodies were low risk, inexpensive, and simple to administer.

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FDA Law Blog

JANUARY 18, 2024

Houck — In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. By Larry K. HHS forwards FDA’s analysis and recommendation to DEA.

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GeriPal

FEBRUARY 9, 2023

For example, we spend the first half talking about a RCT simulation study of clinician verbal and non-verbal communication with a seriously ill patient with cancer. In one room the physician under study interacts with a white patient-actor, and in another room interacts with a Black patient-actor. Amber: I do. You know what?

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GeriPal

APRIL 6, 2023

Today we have a star-studded lineup, including Lexy Torke of Indiana University, who discusses her RCT of a chaplaincy intervention for surrogates of patients in the ICU , published in JPSM and plenary presentation at AAHPM/HPNA. These studies are important. It meets in-person, once a month, over nine sessions. The theme is death.

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GeriPal

MARCH 6, 2025

Alex End Well Talk [link] Resources on the PEACH Program Program Review Paper A recent publication in Longwoods Healthcare Quarterly reviewing the PEACH model. So we did a podcast on aging and homelessness with Margot Kushel in 2023. Today we discuss: What is the best terminology? Homelessness? Marginally housed?

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FDA Law Blog

JUNE 14, 2023

This is about reducing the time and cost and increasing the predictability of going from concept to commercialization.” – Dr. Jeff Shuren During a presentation at the May 17, 2023 Food and Drug Law Institute (FDLI) Annual Conference, CDRH Director, Dr. Jeff Shuren discussed TAP with enthusiasm.

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FDA Law Blog

JANUARY 3, 2024

Enter the FDA’s Center for Veterinary Medicine (“CVM”). Palmer & Riëtte van Laack — Most of us love our furry friends, and with the boom in pet ownership during the pandemic, it is no surprise that the market for pet products has become enormous. So, much like humans, pets are living longer and facing the ailments so common to old age.

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PEMBlog

APRIL 26, 2023

Kit Carney and Dr. Kristen Humphrey discuss gun violence, its impact on our patients and their families, as well as practical tips on advocating for safe storage of firearms, and how we can support victims of violence. I’m Dr. Carney and I am a pediatric resident at Cincinnati Children’s Hospital Medical Center.

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GeriPal

SEPTEMBER 5, 2024

And Bill Andereck is still haunted by the decision he made to have the police break down the door to rescue his patient who attempted suicide in the 1980s, as detailed in this essay in the Cambridge Quarterly of HealthCare Ethics. And he’s also chaired the California Pacific Medical Center’s ethics committee since 1985.

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FDA Law Blog

MAY 21, 2024

29, 2023) (“Basis”); NPRM at 44,603. Scientific Evidence of Marijuana’s Pharmacological Effects, If Known HHS found that marijuana abuse can lead to negative consequences that include addiction and the need for medical attention through poison center calls or emergency room visits. 21 U.S.C. § 21 U.S.C. § NPRM at 44,619.

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GeriPal

DECEMBER 29, 2022

Journal of Patient Experience. I mean, it’s something that frustrates me on a daily basis, the number of times that I’ve had to argue with patients and even my own grandparents. Training Hospitalists in Negotiations to Address Conflicts with Older Adults around Their Social Needs. Geriatrics. December 2020. Transcript.

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GeriPal

JULY 13, 2023

On that podcast he and collaborators tested a combined patient and clinician facing communication priming intervention to promote goals of care conversations. Randy died February 26, 2023. Summary Transcript Summary Today’s podcast is a follow up to our 2018 podcast with Randy Curtis about the Jumpstart intervention. Welcome, Bob.

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Patient-Centered IT Hospital Patients 83

GeriPal

AUGUST 15, 2024

Ongoing reports from patients about anti-Asian hate experiences Should clinicians screen for Anti-Asian hate? This question, while providing an opportunity to talk about direct and indirect experiences, can be asked of all patients, and opens the door to conversations about anti-semitism, islamophobia, or anti-Black racism.

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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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Common Sense Family Doctor

MAY 27, 2025

A Pew Research Center survey found that overall, Americans ranked taste as the most important factor in choosing food, followed by cost, then healthiness and convenience. An Agency for Healthcare Research and Quality evidence synthesis that I previously discussed showed that WIC improves important maternal and child health outcomes.

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Common Sense Family Doctor

APRIL 25, 2025

While I'm grateful for subspecialists who alleviate pain, rescue patients who are unable to breathe on their own, manage complicated fractures, and replace worn-out hips and knees, the gap between the number of family doctors we need and the number we have keeps getting wider. And if you build it, will they come?

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GeriPal

SEPTEMBER 14, 2023

We talk with Bruce Leff and Tacara Soones about the hospital-at-home movement, which has been shown to reduce costs, improve outcomes and improve the patient experience. JAGS Hospital-at-Home Interventions vs In-Hospital Stay for Patients With Chronic Disease Who Present to the Emergency Department: A Systematic Review and Meta-analysis.

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GeriPal

OCTOBER 31, 2024

And the reason why I’m choosing is because it’s respiratory virus season and we don’t want our patients to catch their breath. Alex 00:07 We are delighted to welcome back Lona Mody, who is a geriatrician, translational infectious disease researcher, and professor at the University of Michigan and the Ann Arbor Va.

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