FDA’s Temple To Sponsors: Stop Slaving Over The Mean, Look At Range Of Responses
A look at distribution of responses might have provided more convincing data on a novel surrogate endpoint, FDA’s Bob Temple says at tolvaptan kidney disease advisory committee meeting.
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Termination of the development program for dalcetrapib creates more doubt about the class of CETP inhibitors, long viewed with ambivalence. But important differences in how the drug works compared to rivals leaves room for some to hold out hope for CETP inhibition and the HDL hypothesis in general.
Focusing on orphan-first drugs may be best route to address pricing concerns, Health Affairs study suggests after finding that just one-fifth of spending on 15 top-selling partial orphan drugs was for the drugs’ rare disease indications.
US Remains Conservative On Vaccine Dosing Regimens As CDC’s ACIP Highlights Minimal Comfort With Relying On Unproven Correlates
The Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices concerns about making COVID-19 vaccine dose regimen changes based on unproven immune correlates of protection could be a warning sign to sponsors about roadblocks they might face if updating vaccines to address viral variants or conducting pediatric studies relying on such surrogate endpoints.