Pink SheetSetting a redemption deadline for priority review vouchers at the US FDA may help better stabilize their value, a Sanofi executive suggests. An expiration date for the vouchers, which guarantee an e
Pink SheetThe exigencies of ultra-orphan drug development have provided the early testing ground for the US FDA’s limited use of real-world evidence (RWE) in approval decisions, resulting in 13 approvals identi
Pink SheetThree Harvard Medical School researchers are calling for the US FDA to broaden the definition of "existing therapies" in the criteria for the breakthrough therapy designation to raise the comparison b
Pink SheetThe biggest block to the pharmaceutical industry using real world evidence for regulatory purposes is the inadequate data in electronic health records (EHR), according to FDA's Jonathan Jarow, senior