OTP Town Hall to Discuss Cell Therapy CMC Readiness for Late-Stage INDs

July 30, 2024

Experts from the Food and Drug Administration’s Center for Biologics Evaluation and Research Office of Therapeutic Products (OTP) will host a virtual town hall on Thursday, Sept. 5, to answer stakeholder questions about chemistry, manufacturing, and controls (CMC) data for late-stage investigational new drug applications (INDs). These INDs are intended to collect primary evidence of effectiveness to support a marketing application for cell therapy and tissue-engineered products.

The event will take place from 11 a.m. to 12:30 p.m. ET via Zoom. Registration is complimentary but required to attend.