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Focus on Regulation

Tag Archives: Individual Patient Expanded Access Applications

FDA June 2, 2016 Final Guidances For Industry

On June 2, 2016, FDA issued three final Guidances for Industry—two of the three are aimed at clarifying the expanded access applications and procedures, while the third discusses charging for investigational drugs under an Investigational New Drug (IND) application.

FDA Issues Simpler Draft Form for Individual Patient Expanded Access Applications

On February 4, 2015, the Food and Drug Administration (FDA) issued a new Draft Guidance titled Individual Patient Expanded Access Applications: Form FDA 3926. The Draft Guidance introduces draft Form FDA 3926, which – when finalized – may be submitted by licensed physicians to FDA for expanded access (or “compassionate use”) requests for individual patient Investigational New Drug Applications (INDs).