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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.

As GlaxoSmithKline works to get Shingrix back on track, an FDA approval increases the key vaccine's reach esagonowsky Mon, 07/26/2021 - 16:08