This MAPP describes the policies, procedures, and responsibilities in the Office of Pharmaceutical Quality (OPQ), in collaboration with the Office of New Drugs (OND), for assessing a color additive or a flavor present as an excipient in an oral drug product submitted as part of an investigational new drug application (IND), new drug application (NDA), NDA supplement, or an amendment to one of these submissions, or referenced in a Type IV drug master file (DMF).
Specifically, this MAPP is intended to: (1) identify the information on color additives and flavors to be documented by product quality assessors for Type IV DMFs, INDs, NDAs, and NDA supplements; and (2) delineate when a request for an OND evaluation of a flavor would become necessary during a quality assessment.
This MAPP does not apply to the assessment of color additives and flavors that are part of original abbreviated new drug applications or their supplements because the Office of Generic Drugs evaluates the acceptability of color additives and flavors for drug products submitted in an abbreviated new drug application.
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