OTP Town Hall Will Focus on Gene Therapy Chemistry, Manufacturing and Controls

FDA’s Center for Biologics Evaluation and Research Office of Therapeutic Products (OTP) will host a virtual town hall on April 25 to answer stakeholder questions related to gene therapy chemistry, manufacturing and controls (CMC).

FDA requires sponsors to provide information about CMC as part of investigational new drug, biologics license and new drug applications. CMC information collected during the course of clinical development is used to support license applications.

The program will take place from 11:30 a.m. ET – 1 p.m. ET. Registration is complimentary but required. Attendees may submit questions during the registration process (prior to March 24) or during the live event. Recordings from OTP’s previous town halls are available online.