This guidance provides recommendations to pharmaceutical companies interested in participating in a program involving the submission of chemistry, manufacturing, and controls (CMC) information containing emerging technology to FDA. The program is open to companies that intend to include the technology as part of a regulatory submission including investigational new drug applications (IND), original or supplemental new drug applications (NDA), abbreviated new drug applications (ANDA) or biologic license applications (BLA), or application-associated Drug Master Files (DMF)  reviewed by the Center for Drug Evaluation and Research (CDER), and where that technology meets other criteria described in this guidance.This program does not cover products reviewed by the Center for Biologics Evaluation and Research.

 

FDA GUIDANCE : Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization