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Zdrowie i gospodarka · 18/05/2023

FDA Releases Draft Guidance on Pediatric Drug Development

The FDA has released a draft guidance to help pharmaceutical companies comply with the Pediatric Research Equity Act and qualify for pediatric exclusivity under the Best Pharmaceuticals for Children Act, providing recommendations on pediatric study requirements and the process for obtaining exclusivity.

Source: Federal Register — Food and Drug AdministrationOpen original release →