Operation Trialblazer: Expedited IND delivers a strategic edge in dynamic global landscape
Operation Trialblazer is expected to shape early-stage planning, but experts debate its long term impact.
Regulation
FDA finalises psychedelic clinical trial guidance
Makary resigns, with Diamantas named as acting FDA commissioner
Despite turbulence at FDA, technical staff remain “dedicated,” says CMO
Be nimble, be ready: how to tackle regulatory uncertainty in clinical trials
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
