Presenter
Erin Skoda, PhD
Supervisory Chemist
Division of Product Quality Assessment XVIII (DPQA XVIII)
Office of Product Quality Assessment III (OPQA III)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Abstract
Erin Skoda, a chemist with the FDA’s Office of Pharmaceutical Quality, discusses operational considerations for Drug Master Files (DMFs) and Model Master Files (MMFs). DMFs are confidential submissions providing detailed information about facilities, processes, or articles used in drug manufacturing, processing, packaging, and storing. They allow parties to reference this information without disclosing the contents directly and are reviewed by the FDA when referenced by an application like an NDA or ANDA; DMFs are not approved but assessed as adequate or inadequate. MMFs are submitted as Type 5 DMFs, utilizing existing pathways. The presentation outlines the submission process, starting with a recommended letter of intent for Type 5 MMFs, obtaining a unique DMF number, submitting the file electronically (preferably in eCTD format), and undergoing administrative and scientific review. Scientific assessment typically commences once a DMF is referenced by an application, which requires submitting a Letter of Authorization (LOA). Referencing offers flexibility, allowing applicants to reference an entire DMF or only portions. The FDA shares limited information between the DMF holder and the applicant, emphasizing the importance of direct communication between the parties. DMFs can be updated through amendments, which can be administrative or quality-related, and holders should notify affected applicants of changes.