Zdrowie i gospodarka · 13/06/2018

FDA Announces Draft Guidance for Limited Population Pathway for Antibacterial and Antifungal Drugs

The FDA has released a draft guidance for industry outlining the implementation of the limited population pathway provision of the 21st Century Cures Act, which allows for expedited review of antibacterial and antifungal drugs for rare populations.

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

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