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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GeriPal

MAY 19, 2022

Summary Transcript Summary. A patient is on morphine and you want to convert it to another opioid like hydromorphone (dilaudid). How do you do that? Do you do what I do, pull out a handy-dandy opioid equianalgesic table to give you a guide on how much to convert to? . which advocates for an updated, wait for it… equianalgesic table! . Drew: Yeah.

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FDA Law Blog

SEPTEMBER 26, 2022

FDA published a proposed list on June 13, 2018 (83 FR 27609), which we blogged about here. The list of alternative mechanisms for complying with Part 211 in this FR Notice is not different from what was proposed in the 2018 FR Notice. By way of background, 21 C.F.R. § 21 C.F.R. § through alternative or streamlined mechanisms.

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FDA Law Blog

OCTOBER 25, 2021

It was published approximately three years after the December 7, 2018 release of the proposed rule (see blog post on the proposed rule here ). befitted a very important pathway to market for novel medical devices. The rule became final on October 5, 2021 via publication in the Federal Register. The new rule will be codified in 21 C.F.R.

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PEMBlog

APRIL 20, 2023

A special thanks to Dr. Cristina Tarango, director of the Hemophilia Treatment Center at Cincinnati Children’s and Lisa Littner, Project Manager at Cincinnati Children’s who helped me research and write this post. …and it’s called Hemlibra (Emicizumab) Why this med is important and why kids are on it?

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FDA Law Blog

JULY 10, 2023

Understanding the Traditional 510(k) Review Timeline There are three types of Premarket Notification 510(k)s: Traditional , Special , and Abbreviated. Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 By Philip Won & Adrienne R. But that is only the beginning.

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FDA Law Blog

NOVEMBER 20, 2024

of ISO 10993-1:2018, but is extremely burdensome and not referenced in the related ISO 10993-18. It is recommended to submit a Pre-Submission to the Agency when considering your chemical characterization strategy, especially for any devices/materials with special considerations or use of alternative strategies and solvents.

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FDA Law Blog

FEBRUARY 27, 2023

While no “special registration” will yet be required to engage in telemedicine prescribing of controlled substances, DEA is proposing parameters to guide the practice of telemedicine encounters in a post-COVID world. The Act also established new definitions for “Internet,” “online pharmacy,” “practice of telemedicine,” among others.

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FDA Law Blog

JUNE 23, 2021

For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. Over the years, this function expanded to cancer (renamed the Office of AIDS and Special Health Issues) and, ultimately, all serious and life-threatening diseases (dropping the AIDS nomenclature).

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Physician's Weekly

JUNE 19, 2025

The Health Resources and Services Administration projects a 50% increase in demand for geriatricians from 2018 to 2030, when the entire baby boom generation will be older than 65. Their growth has bolstered primary care, and, like doctors, they can specialize in particular branches of medicine. ” In 27 states and Washington, D.C.,

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Nurse Practitioner Families Family Primary Care 52

GeriPal

OCTOBER 10, 2024

Show me your scars.” Scars, really? I’ve been there. You probably have too. On the one hand, I don’t think interprofessional teamwork needs to be scarring. On the other hand, though it goes against my middle-child “can’t we all get along” nature, disagreement is a key aspect of high functioning teams. Alex 02:38 Love it.

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GeriPal

SEPTEMBER 7, 2023

Summary Transcript Summary The comprehensive geriatric assessment is one of the cornerstones of geriatrics. But does the geriatric assessment do anything? Does it improve outcomes that patients, caregivers, and clinicians care about? We talk about: What is a practical geriatric assessment and how can busy oncologists actually do one? Thank you.

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GeriPal

JUNE 29, 2023

This week we’re going on to episode two, which is for me one of the most special episodes we’ve done in GeriPal for a very, very long time. Eric: And in the end, we have a very special part where we actually get a tour of their gardens outside of the hospice unit. One story that Allan told perfectly sums this up.

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The Clinical Problem Solvers

FEBRUARY 8, 2023

There is a special emphasis on the use of public health models that prioritize harm reduction and person-centered care to prevent drug-related fatalities and curb the opioid epidemic along lines of race and class. 2018 Jun;46(2):404-421. Equity in Progress: Development of Health Equity Curricula in Three Psychiatry Residency Programs.

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Community Patient-Centered Mental Health Board-Certified 52

FDA Law Blog

JUNE 10, 2025

DEA publishes the Special Surveillance List to inform about potential illicit uses of a laboratory supply and reminds that civil penalties may be imposed on businesses that distribute a laboratory supply with reckless disregard for the illegal uses to which it will be put. DEA published the original Special Surveillance in May 1999.

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GeriPal

JULY 13, 2023

Summary Transcript Summary Today’s podcast is a follow up to our 2018 podcast with Randy Curtis about the Jumpstart intervention. It’s really special to be here and to be talking about this paper, which was really important to Randy. They found a difference of 4% in documented goals of care discussions. Is 4% meaningful?

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GeriPal

MARCH 27, 2025

We are delighted to welcome Jennifer Wolf f , who is a health services researcher and gerontologist and professor at Johns Hopkins. Jennifer, welcome to the GeriPal Podcast. Jennifer 00:28 It’s great to be here. But before we dive into the study and the implications it has for the practice that we do, I believe someone has a song request.

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GeriPal

APRIL 21, 2022

The impossiblity which is life, which is everything, and death, which is the end of life. As Mary Oliver tells us In Blackwater Woods , and I’m paraphrasing here, we must to hold it to our bones, knowing our lives depend on it, and when the time comes, to let it go. To let it go. . Poetry helps us grapple with our own experiences of illness.

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FDA Law Blog

MAY 14, 2021

In 2009, Congress specifically exempted “tobacco or menthol” when it prohibited all other flavored cigarettes under the Family Smoking Prevention and Tobacco Control Act (TCA)’s “ Special Rule for Cigarettes.” In the same announcement, FDA also shared its intent to propose a product standard that would ban flavored cigars. 21 U.S.C. §

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FDA Law Blog

MAY 14, 2021

In 2009, Congress specifically exempted “tobacco or menthol” when it prohibited all other flavored cigarettes under the Family Smoking Prevention and Tobacco Control Act (TCA)’s “ Special Rule for Cigarettes.” In the same announcement, FDA also shared its intent to propose a product standard that would ban flavored cigars. 21 U.S.C. §

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Pamela Wible MD

JUNE 19, 2025

Physician burnout describes a dangerous mix of emotional exhaustion, depersonalization, and a loss of meaning in work. It’s now so common that more than half of all doctors report symptoms, with medical students , residents , and even senior clinicians feeling pushed to the brink. But is it really burnout—or something more serious? To be real.

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Physician's Weekly

JUNE 17, 2025

Since the drug trial started in 2018, some of her adult patients have begun living independently, getting into college, and starting jobs — milestones that once felt impossible. Dean attends a special education program, his mother said. “It’s crazy,” said Foley Shenk, who lives in Richmond, Virginia.

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FDA Law Blog

FEBRUARY 12, 2025

For some background (which is covered in more detail in one of our previous posts on the subject ), in 2009, Congress specifically exempted tobacco or menthol when it prohibited all other flavored cigarettes under the Family Smoking Prevention and Tobacco Control Act (TCA)s Special Rule for Cigarettes. 44,484 (July 24, 2013).

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FDA Law Blog

JUNE 23, 2024

Highly concentrated opioid formulations (e.g., fentanyl, morphine, hydromorphone, etc.) used in intrathecal pain therapy have strict sterility and stability requirements and are life-threatening if mishandled. A qualified medical professional must perform the refill; it cannot be done by the patient.

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PEMBlog

MAY 9, 2024

2018 Nov;142(5):e20181009. Epub 2018 Oct 8. Murata S, Okasora K, Tanabe T, Ogino M, Yamazaki S, Oba C, Syabana K, Nomura S, Shirasu A, Inoue K, Kashiwagi M, Tamai H. Acetaminophen and Febrile Seizure Recurrences During the Same Fever Episode. Pediatrics. doi: 10.1542/peds.2018-1009. PMID: 30297499. And you know what?

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