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.

Clinic 52

Clinic Education Clinical Practice Patient-Centered 52

FDA Law Blog

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).

Manufacturing 40

Manufacturing Specialization Provider Medical 40

FDA Law Blog

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.

Telemedicine 59

Telemedicine Telecommunication Telehealth Medical 59

FDA Law Blog

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.

Manufacturing 52

Manufacturing Government Specialization IT 52

FDA Law Blog

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.

Provider 75

Provider IT Engineering Medical 75

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?

Individual 52

Individual Patient-Centered Patients IT 52

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).

Patients 52

Patients Patient-Centered Clinic Community 52

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. “We step into places where other providers may not, and geriatrics is a prime example of that.”

Nurse Practitioner 52

Nurse Practitioner Family Families 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. They can use their training and privilege to advocate for meaningful policy reform.

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%.

Patient-Centered 130

Patient-Centered IT Patients Clinic 130

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.

Specialization 69

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.

Patient-Centered 84

Patient-Centered IT Hospital Patients 84

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. Why did you even bother doing this study? Jennifer 04:34 Yeah, thanks for the question.

Primary Care 80

Primary Care IT Clinic Illness 80

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. To the deeper emotions – of loss and grief, of wonder and transcendence – that are at the heart of the complex care we provide. And along the way, we really felt like we got to the heart of things.

Patient-Centered 93

Patient-Centered IT Community Illness 93

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.

Clinic 246

Clinic Nurse Practitioner IT Medical 246

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 Blog

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?

IT 98

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.

Illness 59

Illness Vaccination Family Families 59