FDA Acknowledges More Diverse Subgroup Data Needed In Trials
FDASIA-mandated report indicates some trials underrepresented some racial groups, but the agency says those subsets may not be the proper groupings in the era of personalized medicine.
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Requiring that underrepresented populations be enrolled based upon disease prevalence is only way to ensure adequate diversity, some stakeholders say; agency continues to prefer more flexible approach offered by guidance, and PhRMA says mandates would lengthen development timelines for new drugs.
After about a week of debate, the Senate overwhelmingly passes its FDA user fee package, with only track and trace to be finalized. House members are scheduled to begin floor debate after Memorial Day in the hopes of sending the bill to President Obama before July 4.
Antibiotic Incentives: FDA’s Woodcock Says LPAD Could Be Better Than Exclusivity, But Questions Remain
Rep. Phil Gingrey, lead sponsor of the Generating Antibiotic Incentives Now Act, says industry still has questions about the proposed approval pathway for antibiotics treating life-threatening diseases, further clouding its prospects.