FDA Law Blog

JULY 31, 2023

Houck — President Barack Obama signed the Comprehensive Addiction and Recovery Act of 2016 (“CARA”) intended to reverse serious prescription drug abuse trend in the United States on July 22, 2016. By Larry K. Letter from Congress of the United States, to Robert Patterson, Acting Administrator, DEA (Dec. 78,282 (Dec.

Electronics 98

Electronics Consulting Patients Medical 98

The Motivated MD

SEPTEMBER 19, 2024

For the better half of 2024, I have been periodically writing posts that are individual articles that double as potential chapters to a future book. Before we discuss each individual savings account, let us first highlight exactly what it means to ‘automate’ your savings. So yes, humans make mistakes.

Finance 52

Finance Individual Education Healthcare Professional 52

GeriPal

DECEMBER 15, 2022

Summary Transcript Summary. We’ve talked at length on prior podcasts about the failures of aducnumab, Biogen, and the FDA’s decision to approve it. . But wait, there’s a shiny new anti-amyloid drug, lecanemab! (No No it’s not just the French version of Aducanumab). . In an article in the NEJM (a published article this time, wonder of wonders!)

IT 105

IT Patient-Centered Healthcare Illness 105

The Clinical Problem Solvers

DECEMBER 20, 2021

Fields Guests: Thu Quach, PhD, and Tung Nguyen, MD Time Stamps 00:00 Introduction 04:00 How Dr. Thu Quach’s and Dr. Tung Nguyen’s journeys shape their work 11:40 Policy work as a way of mitigating burnout 12:55 Balancing individual and communal focus (include?) Insufficient language services (i.e.,

Community 52

Community Patient-Centered Relationship Healthcare 52

GeriPal

FEBRUARY 29, 2024

The hot sauces progressed from mild to extreme (and I mean extreme) heat. Can I just say…it works? Being asked a question with your mouth on fire, sweat streaming down your face, feeling the most awake and terrified you have ever been in your life, forces you to give an unadorned answer, straight from the heart. Lynn: Okay. Anne: GeriPal edition.

IT 126

IT Patient-Centered Illness Education 126

GeriPal

DECEMBER 8, 2022

Integration of Person-Centered Narratives Into the Electronic Health Record: Study Protocol. Connection — The Integration of a Person-Centered Narrative Intervention into the Electronic Health Record : An implementation study. Summary Transcript Summary. Narrative medicine? Because that really is what this is about.

Patient-Centered 115

Patient-Centered Illness Healthcare IT 115

FDA Law Blog

DECEMBER 18, 2022

Generally, FDA’s MDR regulations require device manufacturers to submit Medical Device Reports (MDRs) for individual reportable malfunctions within 30 calendar days of the manufacturer becoming aware of the malfunction. Summary malfunction reports should be submitted electronically on Form FDA 3500A. July 1 – September 30. October 31.

Medical 59

Medical Manufacturing Individual Provider 59