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

FDA Law

SEPTEMBER 26, 2022

Lenz, Principal Medical Device Regulation Expert & Holly N. requires generally that manufacturing of a combination product (CP) must comply with the applicable current Good Manufacturing Practice regulations (cGMPs) for all of its components ( i.e., a drug/device CP must follow the cGMPs for drugs as well as those for medical devices).

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Manufacturing Specialization Provider Medical 40

FDA Law

FEBRUARY 27, 2023

The Ryan Haight Act was enacted to address the legal “grey area” in which prescribers and pharmacies operated via the creation of two new statutory requirements: 1) the at least one “in-person” medical evaluation requirement for prescribing practitioners, 21 U.S.C. § 829(e); and 2) the modified registration requirement for online pharmacies.

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Telemedicine Telecommunication Telehealth Medical 59

FDA Law

OCTOBER 25, 2021

The Medical Device Amendments of 1976 created the initial premarket application (PMA) review and 510(k) substantial equivalence review processes. befitted a very important pathway to market for novel medical devices. Shapiro — After 23 years, de novo classification review finally has an implementing regulation ! Part 860.

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Manufacturing Government Specialization IT 52

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. Patients on emicizumab will have it listed on their medication list. How to know if a patient is on it?

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Individual Patient-Centered Patients IT 52

FDA Law

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). 25, 2014).

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Patients Patient-Centered Clinic IT 52

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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Provider IT Engineering Medical 75

GeriPal

MAY 19, 2022

I think part of it’s the math, but I think what really happened is, I think the story here is that in 2018, MD Anderson published this really landmark study by Dr. Reddy and her colleagues about going from IV Dilaudid to other to oral Dilaudid, oral hydromorphone, I should say, oral morphine and oral oxycodone. Drew: I agree in part.

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IT Patients Individual Relationship 139

Annals of Family Medicine

NOVEMBER 20, 2024

The Centers for Disease Control and Prevention recommends discussing family planning and preconception counseling at the domestic medical exam (DME), yet there is little guidance on specific counseling needs in this population. Population Studied Inclusion criteria were ages 16-45 with a DME performed between 2018 and 2023.

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DO Family Medicine Complication Families 130

Physician's Weekly

JUNE 19, 2025

Pregnant with her second child, she schleps a backpack instead of a traditional black bag to carry a laptop and essential medical supplies — stethoscope, blood pressure cuff, and pulse oximeter. Their growth has bolstered primary care, and, like doctors, they can specialize in particular branches of medicine.

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Nurse Practitioner Families Family Primary Care 52

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. American Medical Association; Manatt Health. Provisional drug overdose death counts. National Center for Health Statistics.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

GeriPal

SEPTEMBER 7, 2023

William: So ASCO decided to make a high priority this year to redo the guidelines, which were originally released in 2018. So I make the point, they often say, “Oh, you have this special population,” like pediatrics, where it’s 10% or something. Do you worry about that? We actually have the majority. William: 80%.

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Patient-Centered IT Patients Clinic 130

GeriPal

OCTOBER 10, 2024

Alex 01:23 And we’re delighted to welcome DorAnne Donesky, who is a palliative care nurse practitioner at Queen of the Valley Medical center in Napa and professor emeritus at the UCSF School of Nursing. Michelle 01:22 Thanks for having us today. DorAnne, welcome to GeriPal. DorAnne 01:36 Good to see you.

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Screening IT Families Family 121

GeriPal

JUNE 29, 2023

On last week’s podcast we interviewed the medical director and the chaplain of the prison’s hospice unit (Hospice in Prison Part 1 ). This week we turn our attention to the inmates. 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.

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IT Families Family Board-Certified 97

FDA Law

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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Specialization Manufacturing Electronics PCP 69

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. So what’s changed since 2018 with Jumpstart? Erin: Yeah, I can go first.

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Patient-Centered IT Patients Hospital 84

GeriPal

APRIL 21, 2022

We talk not only about reading poetry, but also writing poetry, and using poetry in medical education as a healing modality. In medical school, I worked with Mike on the comprehensive care team long before there was Jennifer Temple’s randomized trial of outpatient palliative care for cancer. Mike and I go actually way back.

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Patient-Centered IT Community Illness 93

GeriPal

MARCH 27, 2025

But most people with dementia are initially diagnosed and medically managed in primary care, and they really desire clinicians to initiate these conversations but there are a number of really important barriers for these conversations taking place. And that included scheduling a visit with a, with a facilitator who had been specially trained.

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Primary Care IT Clinic Illness 80

Pamela Wible MD

JUNE 19, 2025

Published 2/5/19, updated 6/19/25) Rowdiest audience ever (at a medical conference at least). 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. Among medical trainees suicide is the number one cause of death today.

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Physician's Weekly

JUNE 17, 2025

GLP-1 agonist medications Ozempic, Wegovy, and others also are delivering dramatic results for millions. For example, up to 15% of patients in the GLP-1 trials didn’t respond to those drugs, and at least one study found the medications didn’t significantly help Prader-Willi patients. Kennedy Jr.

Patient-Centered 52

Patient-Centered Emergency Room Insurance Patients 52

FDA Law

JUNE 23, 2024

The CSA and regulations promulgated by DEA are intended to reduce the potential for diversion and abuse and ensure that controlled substances are dispensed and delivered to patients for a legitimate medical purpose. However, TDD medications are highly concentrated opioids and cannot be self-administered. 2] Why is this an issue?

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IT Medical Patients Specialization 98

PEMBlog

MAY 9, 2024

2018 Nov;142(5):e20181009. Epub 2018 Oct 8. Obviously, you should ask about immunization status and whether or not the child has any underlying medical or neurologic problems or developmental delay. Now, you could prevent the risk of subsequent febrile seizures by putting a kid on prophylactic anti epileptic medications.

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Illness Vaccination Families Family 59