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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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New and Updated FDA Forms

This page provides New and Updated FDA Forms related information.

Updates to Forms FDA 356h and FDA 1571

To align with PDUFA VII , BsUFA III, and GDUFA III requirements as well as make other improvements to data quality and ease of use, FDA has revised form 356h: Application to Market a New or Abbreviated New Drug or Biologic for Human Use and form 1571: Investigational New Drug Application (IND). Use these new versions to ensure new PDUFA, BsUFA, and GDUFA program data are collected. 

Please contact druginfo@fda.hhs.gov or industry.biologics@fda.gov with any questions about form revisions.

Form FDA 356h Revisions

Form Field Update
6 Replaced free form text field with specific data fields for "Authorized U.S. Agent Name"
21

Added checkboxes for:

  • REMS Assessment Report
  • REMS Assessment Methods and Study Protocols
  • Human Factors (specify type: ______) 
25 Removed yes/no “Human Factors Information” checkbox
25 Added new yes/no checkbox for Digital Health Technology (DHT) Data
28 Added new yes/no question “Is this establishment involved in the change described in this supplement?”
28 Replaced free form text field with specific data fields for "Name of Contact for the Establishment"
29 Replaced "BMFs, MAFs, and DMFs" with “MFs, DMFs, and MAFs”
31 Replaced free form text field with specific data fields for "Applicant’s Responsible Official"

 

Form FDA 1571 Revisions

 
Form Field Update
1 Added new checkbox to indicate the FDA center the application is being submitted to: CDER or CBER
7B Field label was updated from “Select One” to "IND Type (select one)"
12A Added checkbox for “Use-Related Risk Analysis” under “Protocol Amendment”
12A Replaced "Human Factors Protocol” with "HF Validation Protocol"
12B Added new question " Does the submission contain: Digital
Health Technology (DHT) data or a proposal to collect DHT data?”
19 Replaced free form text field with specific data fields for "Sponsor or Sponsor's Authorized Representative"

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