The Evolution of Clinical Trials

The Evolution of Clinical Trials – FDA Watch

Shelly and Wayne chat with Steve Grossman, President of HPS Group and author of "FDA Matters: The Grossman FDA report," and Anthony Brogno, Director of Clinical Operations at Lindus Health. You'll hear their thoughts on how drug development, drug approvals, and clinical trials could be evolving under the new administration's FDA; priorities in clinical trails for the new FDA Commissioner; the intersection of budget and the FDA's use of artificial intelligence in its review systems; and much more. In our headlines segment, Shelly and Wayne delve into these major developments: Pharma: FDA Holds Virtual Public Workshop on Cell Therapies and Tissue-Based Products Devices: FDA Issues the Center for Devices and Radiological Health (CDRH) 2024 Annual Report Food: FDA Publishes New Food Contamination Prevention Strategy Cosmetics: FDA Plan on Banning Certain Hair-Straightening Chemicals in Limbo In our Resource Links segment, we listed key documents in our four core areas. To view these links, subscribe, or find out more information about our podcast, visit FDAWatch.net. Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at info@fdawatch.net. Music by Dvir Silver from Pixabay.

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Shelly and Wayne chat with Steve Grossman, President of HPS Group and author of “FDA Matters: The Grossman FDA report,” and Anthony Brogno, Director of Clinical Operations at Lindus Health. You’ll hear their thoughts on how drug development, drug approvals, and clinical trials could be evolving under the new administration’s FDA; priorities in clinical trails for the new FDA Commissioner; the intersection of budget and the FDA’s use of artificial intelligence in its review systems; and much more.

Headlines

Pharma: FDA Holds Virtual Public Workshop on Cell Therapies and Tissue-Based Products

Devices: FDA Issues the Center for Devices and Radiological Health (CDRH) 2024 Annual Report

Food: FDA Publishes New Food Contamination Prevention Strategy

Cosmetics: FDA Plan on Banning Certain Hair-Straightening Chemicals in Limbo

Resource Links

Pharma: FDA cites Indian ingredients supplier for deleting records

Devices: FDA Alerts Patients to Regularly Check Diabetes-Related Smartphone Device Alert Settings, Especially Following Phone Hardware or Software Changes: FDA Safety Communication

Food: FDA recalls over 2 million baked goods over concerns of listeria contamination, including a variety of doughnuts

Cosmetics: CNN Health reports proposed ban on hair-straightening products containing formaldehyde and formaldehyde-releasing chemicals remains in limbo under Trump administration

About Our Guests

Steven A. Grossman

Steve is President of HPS Group and author of “FDA Matters: The Grossman FDA report.”

He co-founded with me the Alliance for a Stronger FDA, which he served as Executive Director, just departing that position to do other things in the FDA area. Earlier, he was Health Staff Director on the Senate HELP Committee and a Deputy Assistant Secretary for Health at HHS. Steve knows more about the FDA budget than just about anyone outside of FDA. 

Anthony Brogno

Anthony is the Director of Clinical Operations with Lindus Health, leading all U.S. based trials and running them radically faster for life science pioneers. His 18 years of industry experience spans across sponsors, CROs, sites and industry consortia.