Recently on 21-December-2022, U.S Food and Drug Administration announced the availability of a draft guidance for industry entitled “Controlled Correspondence Related to Generic Drug Development”.
A controlled correspondence is a correspondence submitted to FDA by or on behalf of a generic drug manufacturer or related industry requesting information on a specific element of generic drug product development or certain postapproval submission requirements.
The purpose of this guidance is to provide information regarding how generic drug manufacturers and related industry representatives can request information about generic drug development via correspondence controlled by the FDA.
FDA will review and respond to 90 percent of level 1 controlled correspondence within 60 calendar days of the date of submission.
FDA will review and respond to 90 percent of level 2 controlled correspondence within 120 calendar days of the date of submission.
FDA will review and respond to 90 percent of submitter requests to clarify ambiguities in the controlled correspondence response within 21 calendar days of FDA’s receipt of the request.
Any other correspondence during an ANDA assessment cycle is considered general correspondence and should be submitted to the ANDA as part of that application's administrative record.
Click this LINK to know in detail about Content of a Controlled Correspondence and How To Submit a Controlled Correspondence.
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