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Suspected Adverse Reaction Form Food and Drug Administration

Suspected Adverse Reaction Form Food and Drug Administration

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Now that you are the sponsor of a Single Patient IND, do you understand the expectations and requirements for treating a patient under expanded access? After the expanded access application is allowed to proceed, a letter is issued. This letter will provide the details of your obligations for safety reporting and annual reports. Follow-up submissions use the same Form FDA 3926 as the initial submission; however, you will only need to complete certain parts of the form. You can think of the form as a cover page. Complete fields 1 through 3 every time Form FDA 3926 is submitted to FDA. Check the box in field 3.b. to indicate it is a follow-up submission. Include the investigational drug or biologic name and the IND number provided by FDA. Remember, fields 4-7 are only for initial submissions, and are not needed for follow-up submissions. For follow-up submissions to an existing expanded access IND, we will focus on fields 8 and 9. In Field 8, enter your contact information. This field sh

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