FDA Form 356h

FDA Form 356h ("Application to Market a New or Abbreviated New Drug or Biologic for Human Use") is the standardized cover form an applicant files with a New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Biologics License Application (BLA). It identifies the applicant and product, states the application type and submission type (original, resubmission, or supplement), indexes the enclosed technical sections, and carries the signed certification statements required for FDA to accept the submission for review. It applies only to drug/biologic marketing applications reviewed by CDER or CBER -- it is not used for medical device submissions, which use a separate CDRH cover sheet (Form 3514).

ByCASRAI Editorial Board

· Last updated 18 Jul 2026

Worked examples

Is an instance

A sponsor completing Phase 3 trials for a new small-molecule drug files an original NDA with FDA's CDER; Form 356h is the first document in the submission, checking the "NDA" box, naming the proposed product, and indexing the CMC, nonclinical, and clinical sections that follow.

Is an instance

A biotech company seeking approval for a monoclonal antibody files a BLA with CBER (or CDER, depending on the product); the same Form 356h is used, with the "BLA" box checked and the certification statements signed by the company's authorized official.

Looks similar, but isn't

Not an instance

A device manufacturer submitting a 510(k) premarket notification for a new diagnostic instrument does not use Form 356h -- CDRH device submissions use Form 3514 (the Premarket Review Submission Cover Sheet) instead, since 510(k)s are reviewed under the FD&C Act's device provisions, not its drug provisions.

FDA Form 356h — “Application to Market a New or Abbreviated New Drug or Biologic for Human Use” — is the cover form filed with FDA at the front of a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), or a Biologics License Application (BLA). It is not the application itself; it is the standardized, structured summary sheet that identifies the applicant, the product, the type of submission, and an index of what is enclosed, and it carries the applicant’s certification and authorized signature. The FDA‘s Center for Drug Evaluation and Research (CDER) uses it for drug applications; the Center for Biologics Evaluation and Research (CBER) uses the same form for most biologic license applications.

What Form 356h captures

Across its sections, Form 356h collects: applicant name and address; the type of application (NDA, ANDA, or BLA, and whether it is an original submission, resubmission, efficacy supplement, or other supplement type); the proprietary and established name of the product, dosage form, route of administration, and proposed indication; whether the submission relies on a proposed or approved Risk Evaluation and Mitigation Strategy (REMS); an index/checklist of the technical sections and enclosures included in the application; and a set of certification statements (e.g., regarding debarment, financial disclosure, and the accuracy of the submission) that the signing official attests to under penalty of the certifications made.

Regulatory basis: NDA, ANDA, and BLA

For drug applications, the content-and-format requirements Form 356h supports are set out at 21 CFR 314.50 (NDAs) and 21 CFR 314.94 (ANDAs, which incorporate 314.50’s format requirements by reference). For biologic applications, 21 CFR 601.2 defines a BLA as “a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce” and likewise calls for Form 356h as the application’s cover documentation. Because the same form serves all three application types, the “type of application” checkbox on the form itself is what tells FDA which regulatory pathway and review division the submission falls under.

When it’s required

Form 356h accompanies an original NDA, ANDA, or BLA submission, and it is also refiled with most post-approval supplements and with a resubmission that follows a Complete Response Letter (CRL) — the letter FDA issues under 21 CFR 314.110 (NDA) when a review cycle concludes without approval, describing the deficiencies that must be resolved. A CRL is distinct from a refuse-to-file letter (issued before substantive review begins, for an incomplete application) and from an approval letter with post-marketing requirements attached (the application is approved). Resubmitting after a CRL means preparing an updated Form 356h reflecting the new submission, not a brand-new application.

What it is not: the 510(k) pathway uses a different form

Form 356h is specific to CDER/CBER drug and biologic applications. It should not be confused with the forms used for medical device submissions to FDA’s Center for Devices and Radiological Health (CDRH). A 510(k) premarket notification — the pathway most moderate-risk (Class II) devices use to reach market by demonstrating substantial equivalence to a legally marketed predicate device — uses FDA Form 3514 (the CDRH Premarket Review Submission Cover Sheet) instead, and other device pathways (Premarket Approval applications, Investigational Device Exemptions) have their own associated cover documentation. A drug/biologic sponsor and a device sponsor are filing structurally different applications under different statutory authority (the FD&C Act’s drug provisions and the PHS Act for biologics, versus the FD&C Act’s device provisions), and the cover forms reflect that split — 356h never applies to a device submission, and 3514 never applies to a drug or biologic one.

Related CASRAI terms

FDA (Food and Drug Administration) — the agency and its centers (CDER, CBER, CDRH) that receive these submissions.
FDA Form 1572 (Statement of Investigator) — a different FDA form entirely, signed by clinical investigators during a trial, not by the sponsor at marketing-application stage.
FDA Form 483 — an inspectional observations form, unrelated to the marketing-application process Form 356h supports.
Investigational Medicinal Product (IMP) — the EU-context analog for a product still under clinical investigation, before an NDA/BLA-equivalent marketing application is filed.
Investigational Device and Humanitarian Use Device (HUD) — for contrast with the device-side submission universe Form 3514 (not 356h) serves.

Use in your systems

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Schema.org DefinedTerm (JSON-LD)

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