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How do you choose the correct FDA submission form?
Identify the application, transaction, responsible signer and intended recipient before choosing a form. Marketing submissions, sponsor IND transactions, investigator commitments, trial certifications, promotional materials and individual-patient expanded access have different purposes. A form’s appearance in the Module 1 explorer does not establish a requirement to submit it directly to FDA.
Before you begin
Orientation to common human-drug and biologic application forms. Section 1.1 is a forms heading, not a requirement to submit every form. This guide does not replace a complete product-specific submission checklist.
What you will prepare: A form-selection record with the purpose, responsible owner, current source and intended delivery route.
Start with the transaction
| Your task | Starting point | Boundary to resolve |
|---|---|---|
| NDA, ANDA or BLA application material | Form 356h guide | Actual application and submission category |
| Sponsor IND submission | Form 1571 guide | Original IND versus an existing IND transaction |
| Investigator commitment for an IND study | Form 1572 guide | Investigator provides it to the sponsor; not a direct FDA filing instruction |
| Clinical-trial compliance certification | Form 3674 guide | Applicability and defensible certification selection |
| Promotional material transmittal | Form 2253 guide | OPDP versus APLB and draft versus final use |
| Individual patient expanded access | Form 3926 guide | Physician-held application and applicable pathway |
This table is an editorial navigation aid. A linked preparation guide does not itself establish whether that form must accompany this submission.
Create a form-control record
Record the application holder, application identifier, intended action, receiving office and person authorized to sign. For each candidate form, retain the official download location, actual revision, instruction revision and any unresolved source mismatch. Compare repeated identity fields with the cover letter and electronic application metadata. Where a number is not yet assigned, follow that form’s instructions; do not populate another organization’s identifier merely to eliminate a blank.
Fictional example: a form is not a filing route
A clinical team places a signed investigator statement in the publishing queue because the explorer lists it under forms. The form itself directs the investigator to provide it to the sponsor. Return the document to the sponsor’s controlled collection workflow and have the submission owner determine what investigator information actually belongs in the FDA submission. If the same request is instead for an IND sponsor cover sheet, use the 1571 preparation path; the two signatures make different commitments.
Resolve four questions before opening the signature workflow
After using the selection table above, prepare a short decision record. This prevents the correct-looking form from concealing an unresolved pathway or recipient.
| Decision | Evidence to obtain | Stop and resolve when |
|---|---|---|
| Purpose | Actual transaction and application record | The request only says “FDA form” |
| Responsible party | Sponsor, applicant, investigator or other real role | The preparer is being assumed to hold the obligation |
| Recipient | Current instructions and controlled process | A sponsor-collected record is queued as a direct FDA filing |
| Edition and output | Official download, actual footer and saved document | Source labels conflict or values fail to survive saving |
Routing exercise: an investigator asks for the “IND form,” but the sponsor needs an investigator commitment while the regulatory team needs a sponsor transmittal. Separate the two tasks and owners before collecting signatures. Correct names entered in the wrong document do not resolve the mismatch.
Check both the form and its instructions because their revisions can differ. Dynamic PDFs may display a viewer message instead of their real fields; use a compatible viewer and inspect the saved result rather than treating the placeholder page as the document.
For sponsor transactions, continue to 1571. For investigator commitments, use 1572. For certification applicability, use 3674. The selection is complete only when the intended task and accountable owner are clear.
Your preparation checklist
0/3 checkedUse this to track your review in this visit. Checks are not saved and do not establish regulatory compliance.
Frequently asked questions
Does the Module 1 forms heading mean every listed form is required?
No. The heading organizes potential documents; applicability follows the actual task and submission context. Determine purpose, responsible party and destination for each form. Do not assemble every listed item into a package merely because the explorer provides a preparation guide.
Should an investigator’s Form 1572 be sent directly to FDA?
The form directs the investigator to provide it to the sponsor, not directly to FDA. The sponsor’s collection and submission responsibilities must be assessed separately. Listing the form in this explorer does not change its stated delivery instruction.
Does a successful official download establish the form revision?
No. Record the actual form footer and instruction revision and inspect the relevant fields. A stable URL can serve a different edition later, and a dynamic PDF may show only a viewer placeholder. Verify the document itself before reusing saved preparation instructions.
Can preparation software decide an unknown certification answer?
No. Missing factual or applicability information must be resolved by the accountable owner. Software can organize inputs and identify inconsistencies, but it cannot make an unsupported statement true, grant signature authority or substitute for the responsible person’s review and execution.
Sources and revisions
Requirements, source recommendations and editorial preparation advice have different roles. Review the scope and revision of the source you use.
FDA resource
FDA: IND Forms and Instructions ↗Live FDA form navigation reopened September 22, 2026. Use each linked form and its instructions, not the navigation date, to establish revision.
Form instructions
Form FDA 1572: Statement of Investigator ↗4/25 form, two pages; printed OMB expiry September 30, 2026. Fields, commitments and sponsor-delivery instruction inspected September 22, 2026.
Guidance
FDA: Submissions of Promotional Labeling and Advertising Materials ↗April 2022 final Revision 1; IV.A and IV.C, VI–VII. OPDP/APLB distinctions; checked September 22, 2026. Legacy XML syntax is not v4 publishing instruction.
Technical specification · placement only
FDA eCTD v4.0 comprehensive hierarchy ↗Version 2.2, February 2025. Section 1.1. A heading identifies placement, not mandatory applicability.