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FDA Stay Informed RSS
- Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act July 26, 2021Section 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.FDA
FiercePharma News RSS
- As GlaxoSmithKline works to get Shingrix back on track, an FDA approval increases the key vaccine's reach July 26, 2021As GlaxoSmithKline works to get Shingrix back on track, an FDA approval increases the key vaccine's reach esagonowsky Mon, 07/26/2021 - 16:08Kevin Dunleavy