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US FDA Advisory Committee Reboot (Part II): The Right Balance For Conflicts Of Interest

 
• By Kate Rawson

After back-and-forth tinkering with CoI restrictions, CDER is still finding it challenging to seat the right experts. Maybe more realistic guidelines are needed.

wooden balance beam
FDA WILL NEED TO BE NIMBLE TO BALANCE THE CONFLICTING DEMANDS ON ITS ADVISORY COMMITTEES • Source: Alamy

If a physician doses 10 patients with an investigational drug as part of a registrational trial, does that implicitly bias him for or against that product? If a medical professional with an expertise in a rare disease is a co-principal investigator, should that categorically exclude her from an advisory committee – even if she is one of the few global experts in that orphan condition?

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US FDA’s March Approval Candidates Take Aim At Established Markets

 
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‘Pipeline In A Pill’ Or Pipe Dream? US FDA’s April Goal Dates Test Expansion Strategies

 
• By Bridget Silverman

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Global Pharma Guidance Tracker – February 2025

 
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EU CHMP Opinions And MAA Updates

 
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