Be nimble, be ready: how to tackle regulatory uncertainty in clinical trials
Rich Pelt, senior director of Global Regulatory Sciences at Pfizer gives tips for navigating the rapidly changing regulatory space.
Regulation
Rare disease developers applaud clarity in FDA guidance
From real to regulatory: why RWD needs trial-grade standards
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
