From real to regulatory: why RWD needs trial-grade standards
Jen Lamppa, VP of Commercial Strategy at Inovalon, says that RWD will be held to the same scrutiny as trial data if used in regulatory submissions.
Regulation
FDA appoints Tracy Beth Høeg as fifth CDER head this year
EuropaBio calls for “bold approach to investment” amid EU Biotech Act
FDA’s revolving door reveals Pazdur as new CDER head
OS endpoint focus will realign industry to “ultimate goal”
FDA creates new pathway for rare disease drugs, analysts unconvinced
Pharma’s AI prospects get nudged into the future with EU’s AI act
Are regulators keeping pace with AI adoption in clinical trials?
