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Presenter urges applicants to submit control correspondence for MDD confirmation
Summary
The presenter recommended that generic applicants seeking confirmation of an MDD submit a control (controlled) correspondence for regulatory assessment, particularly for products with complex dosing or routes like topicals and ophthalmics.
The Presenter recommended an operational path for applicants who need assurance about which MDD the agency will apply to their product: submit a control (controlled) correspondence to request confirmation. "If you're a generic applicant and you have questions about the MDD you think should be applied to your product, you can submit a control correspondence for confirmation of this MDD for your regulatory assessment and drug development," the Presenter said.
The Presenter emphasized that these correspondences are particularly useful for drugs with complex dosing instructions or routes — for example, topicals and products dosed to effect — where labeling often fails to provide a directly calculable mg/day. The agency framed the correspondence mechanism as the recommended route for applicants to obtain clarity before filing or during development.
