Day: January 22, 2026

The era of human-exclusive regulatory review has officially come to an end. With the formal update to SOPP 8217, the FDA is no longer just “experimenting” with machine learning; they are operationalizing it within the core of the IND review process. By introducing a dedicated AI reviewer from the Office of Biostatistics and Pharmacovigilance (OBPV), … Read more

ICH recently updated how the manufacturing section of the CTD is documented. With the release of the ICH M4Q(R2) draft guidance, the long-standing framework established in 2002 is finally getting a high-tech makeover designed to align it with current status of the digital technology. The latest update is a strategic shift toward structured data and … Read more