Newsletter - July 1, 2021
Has FDA Been Corrupted? Tough Questions, Touchy Answers
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...Read More
PROs Have a Bigger Impact on FDA Decisions When Used as Primary Endpoints
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...Read More
Has FDA Been Corrupted? Tough Questions, Touchy Answers
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...Read More
PROs Have a Bigger Impact on FDA Decisions When Used as Primary Endpoints
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...Read More
