Drugs

OGD Four-Part Harmony MAPP

The CDER Office of Generic Drugs (OGD) has published a MAPP, Using Four-Part Harmony in OGD-Related Assessment Communications, that describes how OGD assessors can apply the principles of four-part harmony to enhance the clarity of OGD-related communications. (In this context, four-part harmony refers to the agency’s principle that the four key elements of a regulatory submission — indication, clinical data, labeling, and promotional materials — should align perfectly with each other.)

OGD says the MAPP applies to communications that are sent to applicants during assessments across the product lifecycle, including complete response letters, discipline review letters, and information requests.

“Four-part harmony is intended to ensure that assessors draft clear OGC-related communications to applicants and to ensure that OGD requests information from applicants that is appropriate to address a question or issue raised in a marketing application in an efficient manner,” the MAPP says. “These principles may help applicants provide the necessary information to adequately respond to questions or issues raised during the assessment of their application by FDA.”

The MAPP says four-part harmony recommends that all OGD-related communications address these four essential components:

acknowledge the information submitted by the applicant;
the issue with the submitted information and why it is a problem;
the additional information that is needed or a recommended alternative approach to addressing the issue; and
why the additional information is needed.

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