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Zdrowie i gospodarka · 29/12/2017

Best Practices for Communication Between Investigational New Drug Application Sponsors and the Food and Drug Administration

The Food and Drug Administration (FDA) has released a guidance document outlining best practices for communication between Investigational New Drug (IND) sponsors and the FDA during the drug development process. The guidance aims to facilitate timely, transparent, and effective interactions between the FDA and IND sponsors to bring safe and effective drugs to the American public more quickly.

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