All FDA submission process articles
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JournalNavigating the FDA’s platform technology designation: Key insights and best practices for drug manufacturers
This article discusses the platform technology designation (PTD) initiative, including its key elements, challenges and its overall significance.
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EditorialAdvanced therapies: A maturing regulatory framework
This issue looks at CMC requirements, recent therapeutic innovations in the oncology field, and the complex interconnection between ATMPs and in vitro diagnostic medical devices.
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