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The agency releases guidance on controlled correspondences related to generic-drug development.
As part of the implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA), FDA has released guidance that provides information on the process for submitting correspondence to the agency requesting information related to generic-drug development. The guidance also describes FDA’s process for providing communication related to such correspondence.
Included in the guidance are the definition of a controlled correspondence, guidelines for submitting a controlled correspondence, and information on requests related to inactive ingredients and Q1/Q2 formulation assessment controlled correspondence review disciplines. The guidance also includes information on communications from FDA to requestors that submit controlled correspondence.