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Zdrowie i gospodarka · 02/11/2022

FDA Releases Revised Guidance on Expanded Access to Investigational Drugs for Treatment Use

The FDA is providing a revised draft guidance to address questions and concerns about implementing the expanded access program, which was updated in response to the 21st Century Cures Act and the FDA Reauthorization Act of 2017.

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