Califf's Commentary
Rob CaliffPracticed intensive care cardiology, outpatient cardiology and did clinical research for > 30 years. Founded the Duke Clinical Research Institute. Served as 23rd and 26th FDA Commissioner. Worked at Alphabet from 2017-22.
| Platform |  | Pricing | Only free issues | Publishes | Weekly |
|---|---|---|---|---|---|
| Issues | 39 | Founded | a year ago | Last Issue | 4 days ago |
| Active | |||||
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robcaliff272993.substack.comLatest Issues
Working Together on Truth: The Story of Coethia, Part I
Image credit: Pauline Wee & DAIR / https://betterimagesofai.org / https://creativecommons.org/licenses/by/4.0/
This the first installment of a three-part series in which I talk about some of the serious health challenges posed by medical m...
Finding Our Mission in the Midst of Transformative Change
I recently was invited to deliver a commencement address at the Duke-National University of Singapore Medical School, a school that I had the privilege of helping to start up 20 years ago. I hope you’ll find this to be interesting.
The fol...
The Much-Feared FDA Form 483, Part 3
Hal Gatewood/Unsplash
This is the third in a three-part series on the FDA’s Form 483, a tool that the agency uses to notify firms that an investigator has found evidence for lack of adherence to quality regulations related to the manufactu...
The Much-Feared FDA Form 483, Part 2
Adrien/Unsplash
In Part 1 of this series on the FDA’s use of a regulatory instrument known as Form 483, I put forward my view of the form and how I hope it will be used to improve quality across the board rather than as a single summary es...
The Much-Feared FDA Form 483
US Food and Drug Administration
In this first of three related posts, I’ll be diving into a topic that some may find esoteric, but which I believe it has a significant effect on the efficiency and effectiveness of manufacturing and clinica...
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Practiced intensive care cardiology, outpatient cardiology and did clinical research for > 30 years. Founded the Duke Clinical Research Institute. Served as 23rd and 26th FDA Commissioner. Worked at Alphabet from 2017-22.
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