CMC For 505(b)(2) Applications

By Lynn Gold, PhD, Ken Phelps, Kathryn Wekselman, PhD, RN, and Karen Seta-Aust, PhD, Camargo Pharmaceutical Services, LLC

The Chemistry, Manufacturing, and Control (CMC) Section (Modules 2 & 3 of the Common Technical Document [CTD]) of any application to the FDA will be the cornerstone for demonstrating the quality of any drug product. A clear document that complies with the ICH Harmonized Tripartite Guideline per the ICH Steering Committee Meeting (9 Nov 2000) is instrumental to that process. The objective of this presentation is to outline the variations that can occur from application to application depending on the dosage form, drug product, and type of file under construction, specifically a 505(b)(2) application.