miércoles, 4 de febrero de 2015

CDER SBIA Update: Streamlining the Expanded Access (Compassionate Use) Process - New Draft Guidance, Draft Form, and FDA Webpage

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

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New Draft Guidance, Draft Form, and FDA Webpage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The new draft guidance document, entitled “Individual Patient Expanded Access Applications: Form FDA 3926introduces and describes draft Form FDA 3926 (Individual Patient Expanded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.

The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.

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