jueves, 2 de junio de 2016

Expanded Access: Streamlined options for request, Form 3926, and New Guidances

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

FDA finalizes a streamlined option for physicians to request individual patient expanded access for use of an investigational new drug or biologic
Today, FDA issued three final guidances for industry related to expanded access.  Expanded access is FDA’s process to facilitate the availability of investigational treatment options to patients with serious or immediately life-threatening diseases or conditions who lack therapeutic alternatives.  The first guidance, “Individual Patient Expanded Access Applications: Form FDA 3926” describes a streamlined option for licensed physicians to request use of an investigational new drug to treat individual patients who have exhausted other treatment options, including for emergency use.  When Form FDA 3926 is substituted for the current Forms FDA 1571 and 1572, the agency estimates that each submission will take only 45 minutes, resulting in a significant burden reduction.  Based on comments received from the public, the new form can also be used for follow-up submissions.
The second guidance, “Expanded Access to Investigational Drugs for Treatment Use -- Questions and Answers,” responds to frequently asked questions about the implementation of FDA’s regulations on expanded access to investigational drugs. 
The third guidance, “Charging for Investigational Drugs Under an IND -- Questions and Answers” responds to frequently asked questions about the implementation of FDA’s regulation on charging for investigational drugs under an investigational new drug application (IND) in the context of clinical trials or expanded access for treatment use. 
These steps to simplify and provide clarity about expanded access will help health care professionals, patients and industry to more easily navigate the expanded access process and enable patients who qualify to access potentially life-saving medications more readily.
FDA  developed patient and physician fact sheets to further inform stakeholders about expanded access and has revamped its website to make it more user-friendly.  
FDA will also host a webinar for health care professionals on July 12, 2016 at 1:00 PM which will explain FDA’s expanded access process and the new Individual Patient Expanded Access Application.  FDA will update stakeholders with details when available.

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