2012 Clinic IT Specialization 
FDA Law Blog
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. Each of these De Novos can represent a clinical advance. These legislative changes helped.
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).
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FDA Law Blog
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.
GeriPal
MARCH 20, 2025
I was part of a writing group that wrote clinical guidelines for VSET for voluntarily stopping eating and drinking. 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. We love it when our guests suggest things.
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.
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