Back to: FDA Generic Drugs Forum 2025
Presenter
David Green, MS
Senior Pharmaceutical Quality Assessor
Division of Product Quality Assessment XVII (DPQAXVII)
Office of Product Quality Assessment III (OPQAIII)
Office of Pharmaceutical Quality (OPQ)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
United States Food and Drug Administration (FDA)
Mr. David Green is a chemist and Senior Pharmaceutical Quality Assessor in the Division of Product Quality Assessment XVII, Office of Product Quality Assessment III, Office of Pharmaceutical Quality at the FDA Center for Drug Evaluation and Research. Mr. Green has been with the Agency for almost 17 years and came to the Agency with over ten years of pharmaceutical and biotechnology experience.
Mr. Green received his M.S. (with Thesis) in Chemistry from Syracuse University, and a B.S. in Chemistry from the University of Maryland, College Park. Mr. Green joined the FDA in 2008, as a generic drug chemistry reviewer in the Center for Drug Evaluation and Research. In his current position as Senior Pharmaceutical Quality Assessor with the FDA’s Office of Pharmaceutical Quality, he focuses on the chemistry, manufacturing and controls (CMC) of generic active pharmaceutical ingredients. He is also a drug substance subject matter expert for several regulatory initiative within the Agency.
Abstract
At the 2025 Generic Drugs Forum, David Green, Senior Pharmaceutical Quality Assessor in the FDA’s Office of Product Quality, presents on common deficiencies found in Type II Drug Master Files (DMFs). He outlines the standard CTD format of DMFs and provides a detailed section-by-section review of recurring submission issues. These include incomplete data, missing justifications, inadequate impurity assessments, inconsistent or illegible documentation, and lack of regulatory alignment. Emphasizing the importance of high-quality, scientifically justified submissions, Green advises applicants to utilize available literature, ensure clear impurity identification, include nitrosamine risk assessments, and submit key forms like FDA 3938. His insights aim to help sponsors reduce review delays and achieve first-cycle adequacy more efficiently.