Drug companies considering whether to make experimental medicines available through expanded access will have more answers about ethics reviews and other requirements that are standard for clinical research.
The Food and Drug Administration announced plans to update a guidance last revised five years ago titled, “Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers.”
The official Federal Register notice is scheduled to publish Wednesday. The changes update a guidance released in June 2016 and updated in October 2017 to include additional questions and answers it’s received over the last five years.
The agency hadn’t posted the revised draft ...
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