FDA's CMC Pilot Program Moves Forward

Washington, DC (Sept. 12)—The Office of New Drug Quality Assessment (ONDQA) in the Center for Drug Evaluation and Research (CDER) has approved one new drug application (NDA) under its CMC Pilot Program and has two more applications are under review. The pilot was established last year to provide an opportunity for FDA and industry to explore strategies for including Quality by Design (QbD) principles and process analytical technology approaches in regulatory submissions, explained ONDQA deputy director Chi-wan Chen at the PDA-FDA Joint Regulatory Conference here