CDER SBIA Update: Streamlining the Expanded Access (Compassionate Use) Process - New Draft Guidance, Draft Form, and FDA Webpage

Streamlining the Expanded Access (Compassionate Use) Process:

New Draft Guidance, Draft Form, and FDA Webpage

FDA is announcing an important measure intended to help streamline expanded access to investigational drugs - a much simpler draft form for comment that, when finalized, should accelerate patient access to investigational drugs. This will be an important tool for physicians who treat those patients with serious or immediately life-threatening diseases or conditions for which there are no comparable alternative treatments.

The new draft guidance document, entitled “Individual Patient Expanded Access Applications: Form FDA 3926”introduces and describes draft Form FDA 3926 (Individual Patient Expanded Access—Investigational New Drug Application (IND)). When finalized, draft Form FDA 3926 is intended to provide a streamlined alternative for submitting an IND under § 312.23 for use in cases of individual patient expanded access.

On our updated webpage, you will find general information about expanded access, followed by more detailed information on individual patient access to investigational drugs (including biologics). Please find additional information in the FDA Voice Blog.

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