USFDA Widens Scope of Navigator – Information Tool for Expanded Access

Two examples of the recent steps US FDA has taken in pursuit of improving their expanded access and orphan drug program

FDA is committed to expanding access to safe and effective treatment options for patients with rare, debilitating, and sometimes fatal diseases. These patients face unique medical challenges. Sometimes there isn’t an FDA-approved drug to adequately address the needs of a patient with a rare disease. Therefore, the agency takes new steps to enable more patients with unmet needs to get access to promising treatments prior to full FDA approval.

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