Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act

[FDA]

Section 505B(d)(1) requires FDA to send a PREA Non-Compliance letter to sponsors who have failed to submit their pediatric assessments required under PREA by the final due date, have failed to seek or obtain a deferral or deferral extension, or have failed to request approval for a required pediatric formulation.


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