Overview of FDA's Expanded Access Program (13/14) REdI 2017
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Күн бұрынJ. Paul Phillips provides an overview of the FDA’s expanded access program with a focus on investigational drug and biological products. The program’s role in providing patients treatment access to these products as well
as the regulatory foundation for the program is discussed. The presentation identifies the types of expanded access requests and the criteria that must be met to allow authorization of those requests.
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