FDA Announces Expedited IND Pilot Program Webinar for Qualified Research Institutions
- FDA is hosting an educational webinar on August 6, 2026, to explain a proposed Expedited IND pilot program designed to accelerate time from drug identification to first-in-human clinical trials.
- The pilot would establish a network of Qualified Research Institutions (QRIs)—including academic medical centers, healthcare networks, CROs, and regulatory advisors—to partner with sponsors on FIH protocol development and review.
- Public comments on the program are due by August 24, 2026, via regulations.gov (docket FDA-2026-N-4699).
Operational Impact
CROs designated as Qualified Research Institutions under this pilot may gain a formal FDA-endorsed role in early-stage protocol development and review, potentially creating new service lines and competitive positioning for firms that secure QRI status.
Source: FDA What's New Drugs RSS