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
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Form FDA 365h |
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Section |
Update |
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6 |
Replaced free form text field with specific data fields for “Authorized U.S. Agent Name” |
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21 |
Added checkboxes for:
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25 |
Removed yes/no “Human Factors Information” checkbox |
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25 |
Added new yes/no checkbox for Digital Health Technology (DHT) Data |
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28 |
Added new yes/no question “Is this establishment involved in the change described in this supplement?” |
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28 |
Replaced free form text field with specific data fields for “Name of Contact for the Establishment” |
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29 |
Replaced “BMFs, MAFs, and DMFs” with “MFs, DMFs, and MAFs” |
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31 |
Replaced free form text field with specific data fields for “Applicant’s Responsible Official” |
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Form FDA 1571 |
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Section |
Update |
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1 |
Added new checkbox to indicate the FDA center the application is being submitted to: CDER or CBER |
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7B |
Field label was updated from “Select One” to “IND Type (select one)” |
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12A |
Added checkbox for “Use-Related Risk Analysis” under “Protocol Amendment” |
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12A |
Replaced “Human Factors Protocol” with “HF Validation Protocol” |
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12B |
Added new question ” Does the submission contain: Digital |
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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.