FDA Law Blog

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

JULY 28, 2022

Alex: And we are also delighted to welcome Areej El-Jawahri, who is an oncologist at Massachusetts General Hospital as well, who specializes in blood cancers. But at that time I was struck by how in that field, there wasn’t a focus or really interest in symptom management and support for patients and their families.

Illness 110

Illness Hospital Patient-Centered Patients 110

GeriPal

MARCH 28, 2024

Kate: So it was an embedded alert in the electronic health record and they just clicked those two answers very quickly. Eric: And that’s similar to the 2016 JAMA paper, right? Did it negate everything from the 2016 trial?Palliative Eric: And how did you do that? Why another study? Tom: That’s probably true.

Consulting 115

Consulting Patient-Centered IT Patients 115

GeriPal

FEBRUARY 29, 2024

Anne: Well, speaking of your kids, a very special, sometimes listener, chimed in named Ren Smith. Alex: And, they were talking about how they were so annoyed because they felt like they got called so frequently by companies trying to sell them electronic wheelchairs. Alex: And, it means pain management. Alex: Okay.

IT 126

IT Patient-Centered Illness Education 126

PEMBlog

MARCH 27, 2024

This episode will help you better prepare for and manage children with inborn errors of metabolism in the Emergency Department. My special guest podcaster, Emily Groopman, is an actual Pediatric Geneticist in training and we hope that you will find this episode useful. 2016 Jan;37(1):3-15; quiz 16-7, 47. Pediatr Rev.

Consulting 59

Consulting Individual Families Family 59

GeriPal

APRIL 10, 2025

primary palliative care interventions seem to fail, whereas specialized palliative care interventions have a relatively robust track record of success. I think back in what, May 2016, you published a randomized controlled trial, first author, palliative care and the ED randomized study, cancer patients. Why do so many (most, all??)

Patient-Centered 77

Patient-Centered IT Hospital Patients 77