Day: July 1, 2021

Patient Reported Outcomes (PROs) that capture patient experience data tend to play a central role in FDA decisions about an application when used as primary endpoints in pivotal clinical trials, says a report on FDA’s Patient Focused Drug Development (PFDD) program and its impact on regulatory decisions published last week. PROs are particularly important for … Read more

Suggestions have been made in the media about the impropriety of the process followed by FDA during the review and approval of Biogen’s Aduhelm. While the process followed may not be outrightly illegal, was it ethical, and was it corrupt? It is important to review the facts before we make judgements. The Chief of FDA’s … Read more