Zdrowie i gospodarka · 27/07/2022

General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products; Guidance for Industry; Availability

The US Food and Drug Administration (FDA) has released a final guidance document titled 'General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products' to help pharmaceutical companies conduct clinical trials in newborn populations, finalizing a draft released on August 1, 2019.

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

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