FDA Law

OCTOBER 3, 2022

district court of Massachusetts by former employee and whistleblower Michael Bawduniak in April 2012 as a qui tam action. HHS noticed an increasing trend of illegal kickbacks in connection with speaker programs and in November 2020, the Office of Inspector General issued a Special Fraud Alert on the topic. See United States ex rel.

Consulting 105

Consulting Healthcare Professional Government Specialization 105

FDA Law

AUGUST 18, 2024

The De Novo process provides a regulatory pathway to classify novel devices for which general controls alone or general and special controls provide reasonable assurance of safety and effectiveness for the intended use. The classification order identifies the special controls and therefore is extremely important.

Specialization 69

Specialization Hospital Physicals Provider 69

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).

Patients 52

Patients Patient-Centered Clinic Community 52

PEMBlog

MAY 24, 2023

Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. 2012 Jan;109(3):27-32. 2012 Feb;13(1):35-40. It is also episode 2 in a 5 episode series focused on agitation in children and adolescents. These articles will take another look at the content included in this episode. PMC3272587.

Management 54

Management Patient-Centered Physicals Transportation 54

FDA Law

APRIL 8, 2024

In its report, Drug Shortages: Root Causes and Potential Solutions, FDA explains that the equipment needed to produce sterile injectables is highly specialized and expensive, meaning that in a shortage situation, production capacity cannot be substantially increased without taking the time and expense of procuring and qualifying new equipment.

Supply Chain 59

Supply Chain Manufacturing Government Hospital 59

GeriPal

MARCH 20, 2025

And she was from Oregon, of course, and in Oregon in 2012, she had completed an advanced directive for stopping eating and drinking once she had advanced dementia. Eric 00:13 And Alex, who do you have with us today? Alex 00:14 We have a very full house today. Hope Wechkin brought this topic to us. Thank you, Hope, for bringing a topic to us.

IT 88

IT Patient-Centered Patients Medical 88

GeriPal

AUGUST 1, 2024

Summary Transcript Summary What is a healthy diet and how much does it really matter that we try to eat one as we age? That’s the topic of this week’s podcast with three amazing guests: Anna Pleet, Elizabeth Eckstrom, and Emily Johnston. Emily Johnston is a registered dietitian, nutrition researcher, and Assistant professor at NYU.

IT 116

IT Diabetes Chronic Disease Patient-Centered 116