House Appropriations Committee Embraces Clinical Trial Issues In FY 2022 US FDA Budget Bill
Report language includes several mentions of improving trial diversity and recruitment, while bill offers a 5% increase in funding.
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With more than 1,600 pediatric and related clinical trials in house, the agency wants ideas for how they can be analyzed to advance pediatric drug development.
In report language, the committee funds more CBER cell and gene therapy staff for rare diseases and suggests AI be considered to speed up complex generic assessments.
3,189 Days: Aduhelm Phase IV Timeline Is Long Among Alzheimer’s Drugs And Other Accelerated Approvals
Pink Sheet and Trialtrove analyses show time given Biogen to complete confirmatory trial exceeds duration of most other late-stage trials of anti-amyloid compounds and is almost double the average time allocated for follow-up studies of novel accelerated approvals since 2016; runway could reflect expectations for a longer follow-up period or potential enrollment challenges.