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Zdrowie i gospodarka · 06/02/2019

FDA Publishes Draft Guidance on Premarket Pathways for Combination Products

The Food and Drug Administration (FDA) has released a draft guidance outlining its principles for reviewing combination products, aiming to streamline the development process for safe and effective combination products, in line with the 21st Century Cures Act.

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