FDA Law

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. or that FDA proposes can satisfy the requirements in § 4.4 much like an FDA guidance document.

Manufacturing 40

Manufacturing Specialization Provider Medical 40

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?

Individual 52

Individual Patient-Centered Patients IT 52

FDA Law

NOVEMBER 20, 2024

Since the first issuance of FDA’s guidance Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” in 2016, sponsors submitting premarket submissions to FDA have had the option of using these techniques to evaluate certain biocompatibility endpoints.

Provider 59

Provider Medical Manufacturing Consulting 59

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. Is that right?

IT 139

IT Patients Individual Relationship 139

Physician's Weekly

JUNE 19, 2025

“It’s also often the family member or the person helping to manage them.” 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. Johnson, for example, has advanced training in gerontology.

Nurse Practitioner 52

Nurse Practitioner Families Family Primary Care 52

GeriPal

OCTOBER 10, 2024

In 2018, survey data revealed that only 41% of survey adult practices had the full complement of funded core team members, which is up from 25% of 2016. DorAnne 30:25 I also wanna make a shout out for pain and symptom management with social work and chaplains. So we totally forget that all of us are symptom managers as well.

Screening 120

Screening IT Families Family 120

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.

Patient-Centered 129

Patient-Centered IT Patients Clinic 129

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. Gerald: As soon as they opened this garden up in 2018.

IT 97

IT Families Family Board-Certified 97

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.

Primary Care 79

Primary Care IT Clinic Patient-Centered 79

GeriPal

APRIL 21, 2022

Look also for a forthcoming article by Mike and Redwing in Journal of Pain and Symptom Management on poetry as a healing modality, to be published mid May (will add link when out). That’s coming out in JP… Redwing: JPSM, Journal of Pain and Symptom Management, yeah. Alex: Is that publication out? Alex: May 15th.

Patient-Centered 93

Patient-Centered IT Community Illness 93

PEMBlog

MAY 9, 2024

2018 Nov;142(5):e20181009. Epub 2018 Oct 8. So what’s the evaluation and management for simple febrile seizures? How do we evaluate and manage them? Alright, so what about the management of febrile status epilepticus? Acetaminophen and Febrile Seizure Recurrences During the Same Fever Episode. Pediatrics.

Illness 59

Illness Vaccination Families Family 59