GDF2026 - Managing Your Letters of Authorization (LOAs)
FDA, Office of Pharmaceutical Quality (OPQ) · July 30, 2026
FDA Office of Pharmaceutical Quality (OPQ) supervisor Deborah Johnson delivered a presentation on letters of authorization (LOAs) for type 2 drug master files (DMFs), explaining when LOAs are required, common submission mistakes, how to limit or amend LOAs (facilities/processes), and how missing or outdated LOAs can delay review timelines.
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