New FDA Forms 356h and 1571

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In August 2017, FDA updated both the Form FDA 356h (Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use) and the Form FDA 1571 (Investigational New Drug Application) to include new data fields. FDA asks that all sponsors begin using these new FDA forms 356h and 1571 immediately; however, it can be difficult to tell if you have the current version of these forms because FDA did not update the expiration date for either document.

The easiest way to ensure that you’re using the current version of these forms is to download a new copy directly from the FDA Forms page on FDA’s website.

If you already have a copy and are trying to determine if it is the current version, here are some tips to identify the current version of the forms.

FDA Form 356h

  • The expiration date in the upper right corner of page 1 should be, “March 31, 2020.”

FDA 356h expiration date

 

  • Box 5 on page 1 includes the new data field, “Applicant DUNS” and Box 6, also on page 1, includes the new data field, “U.S. Agent DUNS.” FDA now uses the DUNS number as part of its process to verify facility information.

FDA Form 356h DUNS - new FDA forms 356h and 1571

  • The footer at the lower left of each page should include the text, “FORM FDA 356h (8/17)”

FDA Form 356h footer

FDA Form 1571

  • The expiration date in the upper right corner of page 1 should be, “February 28, 2019.”

FDA Form 1571 expiration date

  • Box 6 on page 1 has been replaced with Box 6A and Box 6B. The new Box 6A collects the IND number that was collected in the old Box 6, while the new Box 6B collects data on whether your IND is a commercial or research IND. FDA intends to use the data from Box 6B to ensure compliance with the eCTD mandate.

FDA Form 1571 IND

  • The footer on the lower left of each page should include the text, “FORM FDA 1571 (8/17)”

FDA Form 1571 footer

Conclusion

We recommend that you begin using the current version of these new FDA forms 356h and 1571 immediately in all of your eCTD submissions. Using an outdated version of these forms could place your submission at risk of a technical rejection by FDA.

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Author: Evan Richardson

Evan Richardson brings over 10 years of experience in regulatory affairs and operations to Synchrogenix. His experience includes stints with pharmaceutical, biotechnology, and medical device companies, where he's specialized in project management, system implementation, eCTD submissions and organizational training.

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