What's New Related to Drugs (vie, 26 abr 2024)
Want to know what's new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc.
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Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act (Fri, 26 Apr 2024)
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 pediatri
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