New FDA Draft Guidance on Expanded Access:

Individual Patient Expanded Access Applications: Form FDA 3926

This guidance introduces and describes draft Form FDA 3926 (Individual Patient Expanded Access—Investigational New Drug Application (IND)). When finalized, draft Form FDA 3926 will be available for licensed physicians to use for expanded access requests for individual patient INDs. Expanded access requests are sometimes referred to as compassionate use requests. Individual patient expanded access allows for the use of an investigational drug outside of a clinical investigation for an individual patient who has a serious or immediately life threatening disease or condition and there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition. When finalized, draft Form FDA 3926 is intended to provide a streamlined alternative for submitting an investigational new drug application (IND) under § 312.23 for use in cases of individual patient expanded access. This draft guidance and draft Form FDA 3926 are not intended to apply to other types of expanded access requests, including requests for expanded access for medical devices.

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