June 17, 2025
Share on PinterestGen Xers and older Millennials are 3 to 4 times more likely to develop appendix cancer compared to their parents, a new study suggests. […]
June 17, 2025
An adolescent-centered approach to contraceptive counseling for adolescents should be informed by evidence, with attention to sexual and reproductive health equity, according to a new policy […]
June 17, 2025
Below are CDER’s COA Qualification Program’s frequently asked questions (FAQs). We also recommend reviewing the general COA FAQ web page. General CDER COA Qualification Program Information […]
June 17, 2025
Colorectal cancer (CRC) survival is longer when it’s the first of multiple primary malignancies than when it’s the second or solo, new data suggest. The findings […]
June 17, 2025
The table below lists qualified Clinical Outcome Assessments (COA). The tables include legacy projects (those submitted prior to passage of the 21st Century Cures Act), as […]
June 17, 2025
How to engage with the Biomarker Qualification Program (BQP) If you have pre-submission or general inquiry questions or you want to make a meeting request, please […]
June 17, 2025
The tables below list information about submissions to the FDA Clinical Outcome Assessments (COA) Qualification Program for which final COA qualification determinations have not yet been […]
June 17, 2025
Under the 21st Century Cures Act,1 enacted on December 13, 2016, a new section 507, Qualification of Drug2 Development Tools (DDT)3, was added to the Federal […]
June 17, 2025
An international expert panel has developed the first consensus-based framework for reporting “set and setting” variables in psychedelic clinical trials. The guidelines create a standardized protocol […]
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