FDA Updates Forms FDA 1571 and FDA 356h: Key Changes

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FDA Updates Forms FDA 1571 and FDA 356h: Key Changes

FDA has released updated versions of Form FDA 1571 (05/2026) and Form FDA 356h (05/2026) to support PDUFA VII requirements and improve data quality and usability.

All future submissions should use the updated versions, as the previous editions have been marked obsolete.

Form FDA 1571 (IND Application)

Version Change

  • Updated from 03/2025 to 05/2026.
  • OMB expiration date extended to July 31, 2027.

Key Changes

  • Separate fields introduced for:
    • Primary SNOMED CT Indication Term (8B)
    • Secondary SNOMED CT Indication Term(s) (8C).
  • Enhanced orphan drug information capture, including rare disease and orphan designation details.
  • Addition of a new question regarding Real-World Evidence (RWE) or proposals to use RWE in Section 12B. The existing Digital Health Technology (DHT) question has been retained.
  • Administrative and formatting updates, including revised continuation pages and streamlined form structure.

Form FDA 356h (Application to Market a New or Abbreviated New Drug or Biologic)

Version Change

  • Updated from 07/2023 to 05/2026.
  • OMB number changed from 0910-0338 to 0910-0001.
  • OMB expiration date updated from March 31, 2026 to July 31, 2027.

Key Changes

  • Section 15 revised to include:
    • Primary SNOMED CT Indication Term (15B)
    • Secondary SNOMED CT Indication Term(s) (15C) replacing the previous single SNOMED CT indication field.
  • Orphan designation information has been restructured and integrated more clearly within the indication section.
  • New question added in Section 26 regarding:
    • Real-World Evidence (RWE) or a proposal to use RWE.
  • Existing question “Only Pediatric Data?” has been revised to “New Pediatric Labeling?”.
  • For ANDA/505(b)(2) submissions, additional structured fields have been added, including:
    • Relied Upon Product Application Type
    • Suitability Petition information (submitted/approved status).
  • Additional clarifications added for 351(k) biosimilar submissions, including Reference Product BLA Holder and BLA Number fields.
Overall Impact The revisions primarily focus on improved capture of:
  • Orphan drug information
  • SNOMED CT-coded indications
  • Digital Health Technology (DHT) usage
  • Real-World Evidence (RWE) usage
  • Additional PDUFA/BsUFA program data elements.
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