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:
|
| 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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