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FDA Looks to Revitalize Compassionate Use Program With Simplified Form, Final Guidance By Zachary Brennan - Published 02 June 2016

The US Food and Drug Administration (FDA) on Thursday finalized two question and answer guidance documents on charging for investigational drugs and expanded access for the compassionate use of investigational drugs for those with life-threatening diseases or conditions, as well as a new streamlined form for applying for expanded access.

Categories: News, US, FDA, Clinical, Compliance, Crisis management, Drugs, Regulatory intelligence, Regulatory strategy

Tags: compassionate use, expanded access, access to investigational drug, access to drug in clinical trials