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How do you prepare Form FDA 356h?
Start with the actual NDA, ANDA or BLA transaction, then reconcile applicant and product identity, application and submission categories, reference information, establishments and contents. Use the current official form with its instructions and resolve the signing arrangement before execution. A previous form is a comparison record, not authority for the next submission.
Before you begin
FDA human-drug and biologic marketing submissions using Form 356h. This guide is not an IND Form 1571 walkthrough.
What you will prepare: A reconciled form ready for authorized review and signature: not a generated or submitted application.
Start with the submission you are actually making
Form 356h identifies a human-drug or biologic marketing submission. Before entering data, write a one-line description of the transaction: application pathway, application number if assigned, submission purpose and current lifecycle stage. Have the regulatory owner confirm that description. A team preparing an IND should establish the appropriate IND form instead of repurposing this marketing-application walkthrough.
The FDA instructions call for a new 356h with each submission. Treat a previous form as a comparison record, not an approved answer sheet for the next sequence. An old contact, changed product presentation or different submission purpose can make a copied form inaccurate.
Practical preparation: collect the controlled applicant/contact record, product identity, application correspondence, proposed submission description, relevant establishment information and the person authorized to sign. Maintain an internal source beside each uncertain value. A blank cell in that working record means “resolve,” not “not applicable.”
Reconcile identity before choosing submission categories
Work through the applicant and product portions using the current form and its instructions. Verify the legal applicant rather than assuming the consultant preparing the package is the applicant. Compare the product identity with the cover letter and application records; resolve spelling, strength and presentation differences with their owners.
The instructions specify a six-digit application number and a four-digit supplement number where applicable. Preserve leading zeros. The submission date should agree with the cover letter. For a new application without an assigned identifier, obtain the appropriate instruction from the regulatory lead; do not manufacture an application number.
A useful review handoff is a short reconciliation table with four columns: form field, proposed value, source record and unresolved question. This is an editorial working aid, not an additional FDA form. It makes disagreements visible before they are carried into the signature copy.
Keep application pathway, submission type and subtype separate
The form asks different questions about the underlying application and the transaction being submitted. Establish each from the approved submission plan; do not select categories because the previous sequence used them.
Field 19 addresses the reference biological product for a 351(k) BLA. Field 20 addresses the listed drug information for a 505(b)(2) NDA or the reference listed drug for an ANDA. When the ANDA reference standard differs from its reference listed drug, the instructions direct the reference-standard information elsewhere in the application, not into field 20.
Fields 21 and 22 distinguish submission type from subtype. Read their definitions together before deciding, then review any dependent fields that become available. If the pathway or lifecycle stage is unresolved, stop those selections and ask the regulatory owner to establish the missing fact.
Worked review: catch a plausible but wrong reference entry
Fictional editorial exercise: an ANDA team has a reference listed drug and a different reference standard. A preparer copies the reference standard into the “basis for submission” field because it was used in comparative testing.
The reviewer should compare the proposed entry with the pathway-specific instructions and distinguish the two roles. Correct the form using the appropriate reference listed drug information, and identify the application location for the separate reference-standard information. Check the corresponding narrative for agreement so the correction does not leave two incompatible descriptions.
The useful output is a resolved discrepancy with its evidence and owner. “The field is filled in” is not a sufficient check. This same review habit applies to legal names, identifiers, references and lifecycle selections; the expected value must come from a controlled source.
Prepare a reviewable signature copy
Complete the remaining applicable fields against the full current instructions, including conditional product information and establishment details. This guide highlights decision points; it does not replace the official field instructions. Review continuation pages as part of the same document and remove unused pages only as the form directs.
For an NDA, the regulation identifies who may sign and addresses a U.S. countersignature when the signer lacks a U.S. residence or place of business. Have the regulatory owner resolve the actual signing arrangement; an authoring tool cannot grant signature authority.
Before handoff, reopen the saved output and inspect the visible values, page breaks and attachments. Record unresolved items for the responsible person. Completion of this preparation checklist records your review activity; it does not submit the form, validate an electronic signature or establish FDA acceptance.
Use a field-to-record reconciliation sheet
Review these relationships before circulating a signature copy. This working sheet is an editorial aid, not an additional FDA form.
| Form decision | Record to compare | Question to resolve |
|---|---|---|
| Applicant and contact | Controlled legal identity and current contact record | Is the preparer being confused with the applicant? |
| Application and supplement | Assigned identifiers and submission history | Are identifiers and leading zeros preserved? |
| Pathway and transaction | Approved submission plan | Are application type, submission type and subtype distinct? |
| Reference product | Pathway-specific basis and instructions | Is an ANDA reference standard being mistaken for its RLD? |
| Contents and establishments | Actual package and relevant facility records | Do selections describe this submission rather than an earlier one? |
| Execution | Authorized official and applicable U.S. signing arrangement | Has the responsible person reviewed the final copy? |
Edition check: the official download inspected October 6, 2026 has a 05/26 form footer; the linked instructions have a 6/24 footer. Read field labels in both. Different revision dates do not justify either ignoring the instructions or assuming an old saved form contains every current field.
Review exercise: the application identifier is correct but the submission subtype was copied from an earlier original application. Reconcile it with the actual transaction and check dependent selections before producing a new signature copy. Correctness of one identifier does not establish correctness of the surrounding choices.
Compare the final identity and purpose with the submission cover letter. Use the form-selection guide when the underlying task turns out to be an IND transaction instead.
Your preparation checklist
0/5 checkedUse this to track your review in this visit. Checks are not saved and do not establish regulatory compliance.
Frequently asked questions
Is Form 356h the right form for a sponsor IND submission?
Form 356h concerns human-drug and biologic marketing applications. A sponsor IND transaction has its own Form 1571 preparation path. Establish the application and task first; a familiar product name or existing marketing dossier does not make the two forms interchangeable.
Should an ANDA reference standard be entered as the reference listed drug?
No. The instructions distinguish the RLD used as the basis for the ANDA from a reference standard that may differ. Provide the appropriate RLD information on the form and place the separate reference-standard information in the application as instructed.
Can a consultant preparing the form sign automatically for the applicant?
Preparation alone does not establish signing authority. Confirm the responsible official or authorized representative and the applicable signing arrangement, including any relevant U.S. countersignature provision for an NDA. The actual authorized person must review and execute the commitments.
Sources and revisions
Requirements, source recommendations and editorial preparation advice have different roles. Review the scope and revision of the source you use.
Form instructions
FDA Form 356h instructions ↗Supplement revision 6/24; six pages. Field labels and reference-product instructions reopened October 6, 2026 against the 05/26 form.
Form instructions
Form FDA 356h: marketing application ↗Form footer 05/26; printed OMB expiry July 31, 2027. Actual fields and footer inspected October 6, 2026.
Regulation
21 CFR 314.50(a): application form ↗NDA content and signature provisions; eCFR current through September 18, 2026.
FDA resource
FDA forms and current downloads ↗Download the current form and compare its revision with the instructions before completing it.
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.