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Fda Form 3674 Download

Fda Form 3674 Download

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Digital document management has gained traction among businesses and individuals. It offers an ideal environmentally-friendly alternative to traditional printed and signed documents, as you can easily locate the necessary form and securely store it online. airSlate SignNow equips you with all the tools required to create, modify, and electronically sign your documents quickly without any holdups. Manage fda form 3674 on any device using airSlate SignNow's Android or iOS applications and enhance any document-centric operation today.

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Instructions and help about fda 3674

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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