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Stability Study Data File Reason Terminology
Definition 1
Terminology developed to support Data File Reasons within the Stability Data Standards. (NCI Thesaurus)
Definition 2
This code should indicate the type of application the data supports or whether the data is submitted to an existing application. The codes indicate that the data is part of an Annual Report, New Drug Application, New Active Ingredient, Biologics License Application, Premarket Approval, or Supplement to an Approved Application. (Food and Drug Administration)
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