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Revisions to FDA-Forms 365h and 1571

Aug 15, 2023 | Drug & Biologic Product Submissions, Pharmaceutical

The US Food and Drug Administration (FDA) has recently made updates to forms 365h and 1571. Form 365h is “Application to Market a New or Abbreviated New Drug or Biologic for Human Use”. These applications are commonly referred to as NDA, ANDA or BLA. Form 1571 is “Investigational New Drug Application (IND)”. These are among the most important eCTD forms involved in your drug or biologic application process.

The goal of these updates is to improve ease of use and increase data accuracy. Additionally, these revisions provide alignment with PDUFA VII, BsUFA III and GDUFA III by collecting appropriate program data. According to the FDA, These changes include identifying if the product is a Commercial IND or Research IND, the identification of Combination Products, and the inclusion of the Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT).

Reed Tech recommends implementing these new forms as soon as possible to align with the latest FDA efforts and, likely, increase the efficiency with which your application is reviewed. To learn more about implementing these new forms, please contact us at [email protected] or +1-215-557-3010.

Details of Changes

Form FDA 365h
Section Update
6 Replaced free form text field with specific data fields for “Authorized U.S. Agent Name”

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
Section 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”

Important Definitions

NDA: New Drug Application   A vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S.

ANDA: Abbreviated New Drug Application   An application that contains data that is submitted to the FDA for the review and potential approval of a generic drug product

BLA: Biologics License Application   A request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce

IND:  Investigational New Drug Application   A request for an exemption to be transported or distributed across state lines before it has an approved marketing application

PDUFA: Prescription Drug User Fee Act   Authorization for FDA to collect user fees from persons that submit certain human drug applications for review or that are named in approved applications as the sponsor of certain prescription drug products

BsUFA: Biosimilar User Fee Act   Authorization for FDA to assess and collect fees for biosimilar biological products

GDUFA: Generic Drug User Fee Agreement   Authorization for FDA to assess industry user fees to bring greater predictability and timeliness to the review of generic drug applications

For questions about eCTD or the changes to FDA-Forms 365h and 1571, please reach out to [email protected] or +1-215-557-3010. To schedule an eCTD consultation, click here.