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    Results:

    Subject Term: "Adverse events"

    1 publication with a total of 1 open recommendation
    Director: John Dicken
    Phone: (202) 512-7114

    1 open recommendations
    Recommendation: To help FDA meet its goal of facilitating expanded access to investigational drugs by patients with serious or life-threatening diseases or conditions, when appropriate, the Commissioner of FDA should clearly communicate how the agency will use adverse event data from expanded access use when reviewing drugs and biologics for approval for marketing and sale in the United States.

    Agency: Department of Health and Human Services: Food and Drug Administration
    Status: Open

    Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.