The Clinical Problem Solvers

DECEMBER 16, 2020

Our guests explain how we can incorporate race-conscious medicine in clinical settings, medical education, and biomedical/epidemiological research to responsibly recognize and address the harms of racial inequality. These factors include a high-protein diet, muscle mass, creatinine generation, and certain medications. link] Tsai J.

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Clinic Education Clinical Practice Patient-Centered 52

BMJ

AUGUST 20, 2021

doi: 10.1136/fmch-2020-000845 The appetite for and ability to collect accurate digital patient-level data in low-resource settings has fueled numerous massive global health initiatives. As impressive as these large numbers may be, the question that is less often asked is “How much of that big data is actually helping us do better?”

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Patient-Centered Clinic Provider Patients 40

FDA Law

AUGUST 23, 2022

Baumhardt, Senior Medical Device Regulation Expert & Richard A. After two negative tests, you should consider a molecular test, or call your healthcare provider. If the third test is negative, you should test again with an antigen test, or get a laboratory molecular-based test, or call your healthcare provider.

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GeriPal

AUGUST 4, 2022

Today we are coming back for more (or less given the content), talking about the following articles with their lead authors: First up, we talk with Ariel Green about her article in JAMA Network on preferred phrases a clinician may use to explain why they should reduce or stop the medication. That’s huge! Welcome, Ariel. Ariel: Thanks.

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FDA Law

SEPTEMBER 19, 2023

Thus, “FTC intends to use its full legal authority” to take action “against companies and individuals that improperly list patents in the Orange Book that do not meet the statutory listing criteria.” And FDA did not provide a substantive response to 5 Requests for Advisory Opinions seeking clarification of the issue.

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FDA Law

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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ABIM

APRIL 24, 2025

Dave, MD, MPH , inquired how stressors may contribute to candidates failing the certification examination and Dr. McDonald stated that knowledge gaps were the primary cause, though ABIM provides safeguards to reduce stress like grace periods and consideration of compassionate exemptions for extraordinary life circumstances.

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FDA Law

MAY 8, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won & Gail H. In February 2020, FDA granted a de novo classification request (DEN190040) for software intended to assist medical professionals in the acquisition of cardiac ultrasound images and that included a PCCP for future software modifications.

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FDA Law

OCTOBER 9, 2023

The ACA sets an annual cap on the amount that insurers can require insured individuals to pay out of pocket for their medical expenses. Once an individual reaches this annual cap, the insurer is solely responsible for covering the individual’s remaining medical expenses that year. Gaulkin & Jeffrey N.

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Insurance Manufacturing Patient-Centered Individual 40

33 Charts

OCTOBER 2, 2021

According to Epic, the number of patient messages spiked 151 percent nationally from the period covering the first 11 weeks of 2020 through the end of the year. The zero-sum medical day In many healthcare systems the Epic feature is turned on and health professionals are expected to respond. And individual practice styles are fine.

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FDA Law

FEBRUARY 23, 2025

To help in evaluating device changes, manufacturers commonly refer to FDAs guidance Deciding When to Submit a 510(k) for a Change to an Existing Device, which provides FDAs interpretation of the changes it believes could significantly affect the safety or effectiveness of a device. Notably, FDAs public WL database only goes back to 2020.

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FDA Law

NOVEMBER 6, 2022

In September 2020, the OIG issued an unfavorable advisory opinion to Pfizer, concluding that the proposal was “highly suspect” under the AKS because one purpose of the program, and perhaps the primary purpose, would be to induce Medicare beneficiaries to purchase Pfizer’s federally reimbursable medication.

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Manufacturing Patient-Centered Healthcare Utilities 83

FDA Law

MAY 4, 2023

In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories. This draft guidance builds on recommendations that FDA initially developed early in 2020, in response to the COVID-19 challenges (see our blog post on these recommendations here ).

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FDA Law

DECEMBER 13, 2023

GeMDAC was established to advise FDA regarding treatments under the purview of CDER’s Division of Rare Diseases and Medical Genetics (DRDMG), within the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine. Note that FDA is currently soliciting applications to staff this committee.

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Patient-Centered Medical Patients IT 59

FDA Law

JULY 10, 2023

Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. By Philip Won & Adrienne R.

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FDA Law

MARCH 4, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Deborah L. In 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) expanded the notification requirement to include reasons contributing to the discontinuance or interruption (e.g.,

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Manufacturing Supply Chain Provider Treatment Plan 59

FDA Law

FEBRUARY 27, 2024

For years after the enactment of the Hatch-Waxman Amendments the PTO interpreted the PTE statute to permit multiple PTEs, provided there are separate, but not necessarily different, regulatory review periods. FDA-2020-E-1840 (July 13, 2020). FDA-2020-E-1840 (Mar. 2020) , has not yet—and to our surprise—ended up in court.

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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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FDA Law

JULY 4, 2023

The CARES Act also provides for an administrative hearing process that may be utilized under certain conditions following the formal dispute resolution process. The draft Monograph FDR Guidance clarifies that FDR is appropriate only when there is a scientific and/or medical dispute related to a final order.

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Utilities Provider Individual IT 52

GeriPal

JUNE 8, 2023

When I’m on palliative care consults and attending in our hospice unit we have to counsel patients about deprescribing and de-intensifying diabetes medications. What are the risks and rewards of new classes of medications? When I’m on nursing home call, the most common page I receive is for a blood sugar value. How high is too high?

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Diabetes Management Patient-Centered Family 73

FDA Law

JUNE 22, 2023

Regarding COVID-19, Tim Stenzel, Director of CDRH’s Office of In Vitro Diagnostics, has stated that “in-home testing and home collections is a top priority” ( June 2020 FDA Virtual Town Hall ); “obviously home over-the-counter tests including rapid antigen tests are a high priority” ( February 2021 FDA Virtual Town Hall ). seeking treatment).

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FDA Law

JUNE 23, 2021

As someone who studied in the fields of public health, medical sociology, and biomedical ethics, I was impressed with how quickly the pharmaceutical and biotechnology arena caught up with what took many decades to occur in the context of the physician-patient relationship.

Patients 52

Patients Patient-Centered Clinic IT 52

BMJ

FEBRUARY 8, 2021

7 The same degree of focus has not been paid to misuse of other prescription medications which also have high abuse potential among youth, including medications such as prescription stimulants, tranquilizers, and sedatives. misuse of prescription medications). 2 Opioids contribute a large share of this overdose crisis.

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The Clinical Problem Solvers

FEBRUARY 8, 2023

Pearls: In 2020, American Indian and Alaska Native (Indigenous) communities experienced the highest drug overdose mortality rate of any racial or ethnic group, also surpassing rates among the non-Hispanic white population. They can use their training and privilege to advocate for meaningful policy reform. She then ties this back to Dr.

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Medical Xpress

JUNE 16, 2025

In a study published in Nature Communications , led by researchers at National Taiwan University (NTU) and National Tsing Hua University (NTHU), scientists used the deepest-ever two-photon calcium imaging in awake mice to directly observe how individual SCN neurons respond to light. The content is provided for information purposes only.

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The Clinical Problem Solvers

MARCH 4, 2024

Together, our guests offer context around how the medical and carceral systems are deeply intertwined and go hand-in-hand. Explain the significance of abolition medicine, and the role of the medical system in upholding and perpetuating carceral logics.

Community 52

Community Education Patient-Centered Relationship 52

Medical Xpress

JUNE 16, 2025

The content is provided for information purposes only. However, we do not guarantee individual replies due to the high volume of messages. The information you enter will appear in your e-mail message and is not retained by Medical Xpress in any form. Your feedback is important to us. What are the consequences?

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Mental Health IT Medical Specialization 52

The Clinical Problem Solvers

FEBRUARY 14, 2022

[link] CPSolvers: Anti-Racism in Medicine Series Episode 14: Race, Place, and Health: Clinician and Community Perspectives Show Notes by Alec Calac February 15th, 2022 Summary: This episode highlights how racism manifests in the built environment, and how community and individual-level efforts can mitigate these inequities. Be curious.

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Community Individual Mental Health IT 52

GeriPal

MARCH 2, 2023

2011-2014 JAMDA 2020 Efficacy of Gabapentinoids: Gabapentinoids for Pain: Potential Unintended Consequences. Eric: Any other interesting tidbits or facts that we should know as providers about gabapentin or Lyrica dosing or pharmacology? It’s not a controlled substance medication. Eric: Are these generic?

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Patient-Centered IT Healthcare Medical 96

ABIM

JUNE 24, 2025

The group discussed policy shifts and potential implications for graduate medical education and health equity. Dr. McDonald acknowledged that recent executive orders have emphasized more competition in medical and legal education accreditation, but reaffirmed ABIM’s commitment to evidence-based practice and health equity.

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GeriPal

JANUARY 25, 2024

Summary Transcript Summary In a JAMA 2020 systematic review of palliative care for non-cancer serious illness, Kieran Quinn found many positives, as we discussed on our podcast and in our editorial. With their regular providers? The article we discuss today, also published in JAMA , addresses these two gaps. David: Thank you.

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Patient-Centered IT Illness Patients 122

ABIM

JUNE 11, 2025

This is now being reviewed by the American Board of Medical Specialties, which oversees ABIM. Johnson, MD, FACP, FIDSA , Senior Vice President for Academic and Medical Affairs, led a discussion with the Infectious Disease Board on community practice in the specialty to create a more inclusive understanding of its role and scope.

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Board-Certified Government Community Education 52

FDA Law

OCTOBER 11, 2023

Snow — On September 18, 2023, FDA published an updated, final iteration of guidance for immediate implementation entitled, “ Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies.” hurricane) or public health emergency (e.g.,

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Clinic Supply Chain Clinical Practice Patient-Centered 64

GeriPal

JANUARY 30, 2025

Alex 01:32 For us, answering that question today, we have Joe Greer, who’s a psychologist and associate professor of psychology at MGH and Harvard Medical School. We didn’t think that there was something unique to the modality delivery in which palliative care was providing that care. Joe, welcome to the GeriPal Podcast.

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GeriPal

MAY 26, 2022

They argue that the current guidelines, which prioritize immunocompromised people and unvaccinated older people on the same level, should be re-done to prioritize the immunocompromised first, and additionally move up older vaccinated individuals or vaccinated persons with comorbidities. Emily: Great to be here. Emily: I do.

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FDA Law

JULY 9, 2024

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & Sarah Wicks & Deborah L. DAP Content In developing DAPs, the Draft Guidance recommends that sponsors consider whether certain demographic groups may have a different response to a medical product regarding either effectiveness or safety. 360j(g)(9)(A)).

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GeriPal

NOVEMBER 2, 2023

Alex: Today we’re delighted to welcome Jerry Gurwitz, who is a geriatrician and professor of medicine at the UMass Chan Medical School. I talked about lack of prestige and respect, and I talked about how healthcare system leaders and medical school deans don’t always seem to value the field of geriatrics.

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