Resources, Guidelines, and Guidance Documents

Boyang Wang of Immortal Dragons explains how FDA's Expedited IND Pilot and QRIs could compress sequential first-in-human steps as China's Decree 818 raises the pace.

Panelists on PharmTech AI Pulse Check debate SURPASS, a new digital-twin trial program, regulatory acceptance, and the data-cleanup burden it will create.

The deadline to comment on FDA's generative AI paper is Oct 19, 2026. We explain why professionals in pharma manufacturing should weigh in.

The FDA expanded Anktiva to BCG-unresponsive papillary-only NMIBC using existing CIS trial data, a precedent with implications for development timelines and supply planning.

AI accountability, faster FDA pathways, rare disease CMC review, and next-gen GLP-1 formulation lead this week’s PharmTech roundup.

Boyang Wang, Immortal Dragons, discusses how the FDA’s Expedited IND Pilot must prove efficiency as sponsors chase the fastest route to valid first-in-human data.

Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about rare disease treatment development and navigating the FDA’s Rare Pediatric Disease Priority Review Voucher Program.

The FDA’s Rare Disease Framework Initiative brings risk-based CMC review and pre-approval inspections into scope for sponsors, CDMOs, and quality teams.