Drug Master File Example

Introduction to the Drug Master File (DMF) Review Process

Erin Skoda from the Office of Pharmaceutical Quality, Division of Lifecycle API, discusses the Drug Master File review process from a timeline perspective with an emphasis on key points to be covered during the workshop. Learn more at: https://www.fda.gov/drugs/news-events-human-drugs/drug-master-file-dmf-and-drug-substance-workshop-03032021 ...

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