Drug Fix: US FDA Adcomm Open Public Hearings, Clinical Trial Diversity Plans, Stealth’s Elamipretide
Pink Sheet reporter and editors discuss Richard Pazdur’s call for more diverse opinions in FDA advisory committee meeting open public hearings (:36), agency questions about the stakeholders sponsors consult to execute clinical trial diversity plans (20:52), and Stealth BioTherapeutics’ application for the Barth Syndrome candidate elamipretide getting reviewed (32:23).
More On These Topics From The Pink Sheet
Adcomm Open Public Hearings Have Become Too Sponsor-Driven – US FDA's Pazdur: https://pink.citeline.com/PS150077/Adcomm-Open-Public-Hearings-Have-Become-Too-SponsorDriven--US-FDAs-Pazdur
Clinical Trial Diversity Requires Sponsors Work With An Assortment Of Patient Advocates, Community Organizations: https://pink.citeline.com/PS150081/Clinical-Trial-Diversity-Requires-Sponsors-Work-With-An-Assortment-Of-Patient-Advocates-Community-Organizations
Stealth’s Elamipretide Gets US FDA Review, But Same Questions Linger: https://pink.citeline.com/PS150070/Stealths-Elamipretide-Gets-US-FDA-Review-But-Same-Questions-Linger
Drug Fix: US FDA Adcomm Open Public Hearings, Clinical Trial Diversity Plans, Stealth’s Elamipretide