FDA Forms 356h and 1571: The Complete Master Guide

Two forms decide how your application is read before anyone reads it

Every drug application in the United States starts with a cover sheet, and that cover sheet is not decoration. Form FDA 356h fronts every NDA, ANDA and BLA. Form FDA 1571 fronts every IND. Before a reviewer opens a single module, these forms tell FDA what you are filing, where it should go, who is behind it, where it is made and who answers the phone.

Now FDA has revised both. The agency says the changes align the forms with PDUFA VII, BsUFA III and GDUFA III and improve data quality and ease of use. Read that again: data quality. FDA is not tidying paperwork. It is turning two cover sheets into structured data feeds.

This guide puts everything in one place: what the forms are, why they exist, what changed in 2023, what the May 2026 editions are reported to add, how to code them, which errors stall applications, and a working checklist for regulatory affairs, regulatory operations and eCTD publishing teams. Read it once and you will not need to hunt through five other pages.

The quick answer: what changed and what did not

FDA revised both forms, and the direction is clear: more structured data, fewer free text boxes, more flags for modern submission content. As of 2 October 2026, here is the short version.

What: Form FDA 356h (NDAs, ANDAs, BLAs) and Form FDA 1571 (INDs) were both revised.
Why: To align with PDUFA VII, BsUFA III and GDUFA III requirements and to improve data quality and ease of use.
The 2023 wave: A CDER or CBER checkbox on the 1571, digital health technology questions on both forms, new REMS and human factors checkboxes on the 356h, and structured name fields replacing free text.
The May 2026 editions, as reported by industry: Form 1571 moves from the 03/2025 edition to 05/2026. Form 356h moves from 07/2023 to 05/2026. Both add primary and secondary SNOMED CT indication terms, stronger orphan drug capture and a real world evidence question. Both now show an OMB expiry of 31 July 2027.
The deadline: FDA encourages use of the revised forms. The material reviewed names no mandatory transition date.
The smart move: Treat every older edition as retired. Update templates, RIM configurations, QC checklists and SOPs now, and confirm the current forms sit in Module 1 of every new submission.

One warning before you go further. Field numbers shift between editions. Never edit a template from memory or from any article, this one included. Download the form, read the edition date in the footer, and work from the document itself.

What the forms are, who files them and why the law cares

Both forms are legal gateways, not courtesy sheets. Form FDA 356h, titled Application to Market a New or Abbreviated New Drug or Biologic for Human Use, is the application form that satisfies the requirement under 21 CFR 314.50(a), 314.94(a)(1) and 601.2(a). Form FDA 1571, titled Investigational New Drug Application (IND), is the IND cover form required under 21 CFR 312.23(a)(1).

Item	Form FDA 356h	Form FDA 1571
Full title	Application to Market a New or Abbreviated New Drug or Biologic for Human Use	Investigational New Drug Application (IND)
Filed with	NDAs, ANDAs, BLAs and their supplements and amendments	INDs and the submissions that follow them
Centers	CDER and CBER	CDER and CBER, chosen by a checkbox since 2023
What it carries	Application summary, submission type, indication, facilities, contacts, responsible official	Sponsor, IND type, indication, content of the submission, sponsor representative
Where it sits in eCTD	Module 1, Forms	Module 1, Forms

The 356h does double duty. FDA's own guidance calls it both a summary of administrative information and the repository of complete information on every manufacturing, packaging and control site for the drug substance and drug product. Applications with complete facility information on the form see fewer information requests and fewer refuse to file decisions.

Signature matters too. FDA's biologics review procedures state that the person who signs the 356h is presumed to have signatory authority for the company and is treated as an authorized official. A signed 356h should accompany every supplement, because it helps route the submission to the right division.

A short history: from 1997 to the 2026 editions

The 356h is nearly three decades old and has been rebuilt more than once. The pattern never changes: every revision asks sponsors for more precise data.

When	Event	What it meant
May 2026	Editions dated 05/2026 reported for both forms	Primary and secondary SNOMED CT terms, orphan data, RWE question, OMB expiry 31 July 2027
July 2023	Revised Form 356h, edition 07/2023, released	A four page form with many new boxes; OMB expiry 31 March 2026
March 2023	Revised Form 1571 released with instructions	CDER or CBER checkbox, DHT question, expiry 31 March 2025
May 2018	Form 1571 updated	Commercial or research IND flag, combination product identification, SNOMED CT indication coding
May 2017 and May 2018	eCTD becomes mandatory, first for NDAs, ANDAs and BLAs, then for commercial INDs	The forms now travel inside Module 1 of electronic submissions
8 July 1997	Harmonized Form 356h announced in the Federal Register	One form for CDER and CBER; one BLA replaces separate product and establishment license applications; NDA and ANDA use required from 8 January 1998

Notice how slowly the form moved for years and how fast it moves now. Structured data is the new currency at FDA, and the cover sheets are where it is collected.

Why FDA keeps revising: the user fee machine behind the forms

The forms change because the money changes. PDUFA, the Prescription Drug User Fee Act, began in 1992. BsUFA covers biosimilars and GDUFA covers generics, both introduced in 2012. Each program runs in five year cycles, and PDUFA VII, BsUFA III and GDUFA III cover fiscal years 2023 through 2027.

Industry pays fees. FDA commits to review goals, reports on its performance and accepts program commitments. To report honestly, FDA has to count: how many applications are for orphan products, how many are combination products, how many carry digital health data, how many include REMS or human factors material. The cheapest place to count is the cover sheet.

FDA has been blunt about the problem. Its own presentation on the forms lists the pain: discrepancies in form data and incorrect use of fields increase manual processing, sponsors who reuse old forms pass extraneous or wrong information to FDA, and unfilled fields create extra work that can affect review. The revisions are the fix.

The lesson is simple. Your cover sheet is no longer a letter to a reviewer. It is a record in a dataset, and datasets punish inconsistency.

The 2023 revision, field by field

FDA's own change summary lists the 2023 edits to both forms. Almost every one swaps a free text box for something structured or adds a flag for newer submission content.

Form FDA 356h

Field	Change	What it means for you
6	Free text replaced with specific data fields for Authorized U.S. Agent Name	Enter the agent's name in structured fields and keep it identical to your other records
21	New checkboxes for REMS Assessment Report, REMS Assessment Methods and Study Protocols, and Human Factors (specify type)	Flag REMS and human factors content at the cover level
25	Yes or no Human Factors Information checkbox removed	Human factors is now declared in field 21
25	New yes or no checkbox for Digital Health Technology (DHT) Data	Answer yes only when the submission truly contains DHT data
28	New yes or no question: Is this establishment involved in the change described in this supplement?	Mark each establishment correctly on CMC and efficacy supplements
28	Free text replaced with specific data fields for Name of Contact for the Establishment	One contact per establishment, entered in structured fields
29	Label changed from BMFs, MAFs, and DMFs to MFs, DMFs, and MAFs	A labeling tidy up
31	Free text replaced with specific data fields for Applicant's Responsible Official	Structured name entry; keep it consistent with the signatory

Form FDA 1571

Field	Change	What it means for you
1	New checkbox to indicate the center: CDER or CBER	Choose the center deliberately; it drives routing
7B	Label changed from Select One to IND Type (select one)	Declare commercial or research IND clearly
12A	New Use Related Risk Analysis checkbox under Protocol Amendment	Tick it when that content is in the amendment
12A	Human Factors Protocol renamed HF Validation Protocol	Use the new term in your templates and cover letters
12B	New question: does the submission contain DHT data or a proposal to collect DHT data?	Ask clinical teams before you file, not after
19	Free text replaced with specific data fields for Sponsor or Sponsor's Authorized Representative	Structured entry of the sponsor contact

Two more details from industry commentary. A New Investigator checkbox also appeared in field 12A of the 1571. And both forms gained usability buttons at the top of each page to reset the form, import or export data, and skip to the next page. Use them. Resetting a form is safer than overwriting an old one.

The May 2026 editions: what is reported to be new

Industry summaries report that FDA has released new editions of both forms, each dated 05/2026, and has marked the previous editions obsolete. Treat the details below as reported, and verify them against the forms on FDA's website.

Item	Form FDA 1571	Form FDA 356h
Edition replaced	03/2025	07/2023
New edition	05/2026	05/2026
OMB expiry	Extended to 31 July 2027	Moved from 31 March 2026 to 31 July 2027
OMB control number	Unchanged in the summaries	Reported to change from 0910 0338 to 0910 0001 (written with the usual hyphen on the form)

What changed on the 1571 (IND)

Separate fields for a Primary SNOMED CT Indication Term (8B) and Secondary SNOMED CT Indication Term(s) (8C).
Better capture of orphan drug information, including rare disease and orphan designation details.
A new question in section 12B on real world evidence, or a proposal to use it. The DHT question stays.

What changed on the 356h (NDA, ANDA, BLA)

Section 15 now carries a Primary SNOMED CT Indication Term (15B) and Secondary SNOMED CT Indication Term(s) (15C), replacing the single SNOMED field.
Orphan designation information is restructured and sits more clearly inside the indication section.
A new question in section 26 on real world evidence or a proposal to use it.
Additional PDUFA and BsUFA program data elements.

The overall picture is consistent: better capture of orphan status, SNOMED coded indications, DHT use, RWE use and program data. One honest caveat. These field numbers come from industry summaries of the new editions. Open the actual PDF before you rewrite a single template.

SNOMED CT: the field most teams get wrong

SNOMED CT is the required FDA terminology standard for coding the indication in IND, NDA, BLA and ANDA submissions. It is supported by the National Library of Medicine, the CDC and the Office of the National Coordinator for Health Information Technology. New versions of the US Edition appear every March and September.

The rule that decides quality is granularity. Use the term with the highest granularity available. A broad code such as 38341003, Hypertensive disorder, systemic arterial (disorder), is valid. If your indication is narrower, a narrower concept exists and FDA wants it.

How to code an indication properly:

Write the indication wording exactly as proposed in the application.
Search the SNOMED CT browser for the most specific concept that matches that wording.
Copy the full pre coordinated expression, code and term together.
Paste it into the SNOMED field of the form. In the May 2026 editions, that means a primary term and, where needed, secondary terms.
Read the indication text and the SNOMED term side by side. They must describe the same condition.
Where the form offers a continuation page for extra indications, use it and code each one.

FDA's own list of recurring form errors includes inconsistent data between the indication text and the SNOMED code and description. That is an own goal. Put a second person on this check, every time.

The primary versus secondary split reads naturally: the primary term should capture the main proposed indication and the secondary terms the additional ones. Confirm that reading against the instructions for your edition before you standardize it in your SOP.

Real world evidence and digital health technology: the two new signals

FDA now asks, on the cover sheet, whether a submission contains digital health technology data or proposes to collect it. The May 2026 editions are reported to add the same kind of question for real world evidence. These are not formalities. They are signals about what FDA wants to see more of.

The policy backdrop supports that reading. In late 2025, FDA announced that it would accept real world evidence in certain device submissions without always requiring identifiable patient level data, and said it intends to consider updating its guidance for drugs and biologics. Cancer and cystic fibrosis registries were named as examples of data sources this could unlock.

What this means in practice:

A yes is a routing and tracking event. It tells FDA how many files carry this content.
Teams must decide before filing. Clinical, biostatistics and data science groups should tell regulatory affairs whether any RWE or DHT content is in the package.
Answer precisely. Over declaring creates noise. Under declaring creates a mismatch between the form and the body of the file.
Keep the answer consistent across the cover letter, the form and the relevant protocol or report sections.

The errors that stall applications

FDA's own presentation on the forms names the recurring problems, and its guidance on facility information explains what incomplete forms cost: more information requests and more refuse to file decisions. Here is the working list.

Error	What goes wrong	Fix
Reusing a previously filled form	Extraneous or wrong information reaches FDA	Start every submission from a fresh download, or reset the form
Orphan designation ticked without a designation number	Incomplete record and a follow up from FDA	Enter the number whenever the box is ticked; check it at QC
SNOMED code that does not match the indication text	A data mismatch FDA itself calls out	Second person reads code against text
Skipping fields that apply	Extra manual effort that can affect review	Complete every applicable field; read the form instructions
Incomplete or wrong facility information	Information requests and refuse to file decisions	List every proposed commercial and development facility; reuse an existing FEI, never request a second
Wrong submission type or supplement subtype	Reviewers correct it; CBER can upgrade a CBE or CBE 30 supplement to a PAS and says so in its acknowledgment letter	Confirm type and subtype against the change before release
Missing signature or unclear signatory	Delay in routing	Sign every 356h, supplements included, with someone holding signatory authority
Using an old edition	New program data never collected	Check the edition date at QC

None of these needs genius to prevent. They need a checklist and the discipline to use it.

Mandatory or optional? The deadline question, answered honestly

FDA's notice tells sponsors to use the new versions so that new program data are collected. In the material reviewed, it does not state a mandatory implementation date or transition deadline. Law firm commentary goes further and says companies are required to use the most current versions, and industry summaries report that the prior editions are marked obsolete.

History offers two lessons. In 1997, when FDA harmonized the 356h, it set a hard date and ran an interim period when old and new forms were both acceptable. This time there is no such date. And when the 1571 passed its printed expiry in March 2022, sponsors kept using it for about a year while FDA finished its replacement. FDA lived with it.

So here is the honest position. FDA has not said it will refuse a filing for an old edition, and nobody should pretend it has. But two quiet costs remain. The old form misses the new program data, and a 356h edition carrying an OMB date of 31 March 2026 now looks stale on its face.

The decision is easy. Switching costs a few hours of template work. Not switching risks information requests and data gaps. Use the current edition for every submission from today. Waiting for a deadline is a plan for teams that enjoy information requests.

The compliance playbook for RA, regulatory operations and eCTD teams

Use this sequence. It covers templates, systems, checklists, procedures and Module 1.

Download both forms fresh from FDA's forms page. Record the edition date and OMB expiry in your template register.
Replace every submission template and every prefilled copy. Never reuse an old filled form.
Review RIM system configurations and controlled documents. Add or adjust metadata for SNOMED indication terms, orphan status, RWE, DHT, REMS and human factors flags.
Update publishing and QC checklists with five checks: edition date, indication text against SNOMED term, orphan designation number, signature, facility identifiers.
Review SOPs and submission workflows. Add an intake step where clinical, device and data teams declare RWE, DHT, REMS, human factors and combination product content before regulatory affairs completes the form.
Verify that the latest forms are included in Module 1, in the Forms section, of every original submission, amendment and supplement from now on.
Train the team with a one page job aid and a short briefing. Show the old field next to the new field.
Audit your last twenty submissions for the errors in the table above, then fix the root cause, not the instance.
Diarize a SNOMED review every March and September, when new US Edition versions appear.
Keep FDA's contacts handy: druginfo@fda.hhs.gov for CDER questions and industry.biologics@fda.gov for CBER questions.

Team	Owns	Must check
Regulatory affairs	Form content, signatory, submission type	Indication coding, orphan number, contacts
Regulatory operations	Templates, RIM configuration, version control	Edition date, OMB expiry, template register
eCTD publishing	Module 1 placement, final QC	Right forms in the right place, signed copy present
Clinical and data science	Declaring RWE and DHT content	Accuracy of the yes or no answers
CMC and quality	Facility list and change description	FEI, DUNS, establishment involvement in supplements

What Indian and other international exporters must watch

Indian companies are among the most active ANDA filers in the world, and many are also NDA applicants and DMF holders. Foreign sponsors feel form errors harder, because distance multiplies every correction cycle. Watch these points.

The U.S. agent. Field 6 on the 356h now uses structured data fields for the Authorized U.S. Agent Name. Make sure the agent's details match across forms, registrations and cover letters.
Facility identity. FDA guidance ties the facility section to FEI and DUNS numbers. If a site already has an FEI, do not request a second one. List every drug substance, drug product, packaging and testing site that belongs in the application.
Contacts and officials. The establishment contact and the responsible official now use structured name fields. Spell names the same way on every form and every signature block.
Supplements. For CMC and efficacy supplements, mark whether each establishment is involved in the change. Multi site manufacturers should prepare a facility matrix before anyone touches the form.
Vendors and CROs. Publishing vendors and regulatory service providers often hold stale templates. Put the current edition and a version check into the service agreement.
Drug master files. FDA has discussed a new Form FDA 3938 for DMFs. DMF holders should check the status on FDA's forms page and confirm what applies to their files.
Time zones. Build the QC step so a form can be checked and released without waiting for a U.S. counterpart.

Practitioner FAQ

Which edition do I use today?
The current edition on FDA's forms page. Industry summaries put both forms at 05/2026. Always read the edition date in the form footer.

Do I need to refile pending applications?
FDA has not said so in the material reviewed. Use the current edition for your next submission, and ask FDA if you have a specific concern.

Is the 356h only for NDAs?
No. It also fronts ANDAs and BLAs, and the supplements and amendments that follow them.

Does the 1571 go only with the original IND?
It is required with the original IND under 21 CFR 312.23(a)(1), and FDA's instructions treat it as the cover form for later IND submissions as well. Follow the instructions published with the form.

Where do the forms go in an eCTD?
Module 1, in the Forms section.

My template shows an expired OMB date. Is that a problem?
History shows FDA tolerated an expired 1571 for about a year. Do not depend on that. Replace the template.

Who signs the 356h?
Someone with signatory authority. FDA's biologics procedures presume the signer holds it.

Where are the instructions?
FDA publishes instructions for each form beside the form itself.

Who do I ask?
druginfo@fda.hhs.gov for CDER matters and industry.biologics@fda.gov for CBER matters.

What comes next: expect another revision

Three signals point to more change. First, the reported OMB expiry of 31 July 2027 means FDA must renew both forms inside the next year. Second, PDUFA VII, BsUFA III and GDUFA III run through fiscal year 2027, so the next reauthorization will bring fresh data demands, and the forms are the natural place to collect them. Third, every revision since 2018 has added structure: SNOMED coding, structured names, yes or no flags, program tags.

Expect more of the same. Build your process so a form change is a ten minute update to a controlled template, not a scramble. The winning teams do not guess the next field. They run RIM systems, checklists and SOPs that can absorb any field.

The bottom line

Cover sheets are data now. FDA says so itself, in plain language: data quality, program alignment, ease of use. The 2023 edits proved the direction, and the May 2026 editions push it further with primary and secondary SNOMED terms, orphan data and a real world evidence flag.

You do not need a deadline to act. Download the current forms. Replace your templates. Update your RIM, your QC checklists and your SOPs. Check that Module 1 carries the right edition in every submission from today. Code the indication carefully, and have a second person read the code against the text.

Regulatory affairs rarely gets credit for the application that sailed through. It gets blamed for the one that stalled on a cover sheet. Be the team that never has to explain a form error to a reviewer.

References

U.S. Food and Drug Administration, New and Updated FDA Forms: Updates to Forms FDA 356h and FDA 1571 (fda.gov), content dated 7 September 2023.
U.S. Food and Drug Administration, Form FDA 356h and Form FDA 1571 with their instructions (fda.gov).
U.S. Food and Drug Administration, Guidance on Identification of Manufacturing Establishments in Applications (fda.gov).
U.S. Food and Drug Administration, presentation on regulatory submissions, forms and challenges with Forms 356h and 1571 (fda.gov).
U.S. Food and Drug Administration, Updates to FDA Forms 356h and 1571: Commercial versus Research and SNOMED CT (fda.gov).
FDA Center for Biologics Evaluation and Research, SOPP 8401.2 (fda.gov).
Federal Register, Volume 62, Number 130, 8 July 1997, notice on Revised Form FDA 356h (govinfo.gov).
U.S. Food and Drug Administration, press announcement on real world evidence in drug and device application reviews (fda.gov).
American Pharmaceutical Review, FDA Updates Form 356h and Form 1571.
Masuu Global, FDA Updates Forms FDA 1571 and FDA 356h: Key Changes (masuuglobal.com).
Reed Tech, Revisions to FDA Forms 356h and 1571, August 2023 (reedtech.com).
Premier Consulting, New FDA Forms for INDs, NDAs, and BLAs: What to Know Before Submitting (premierconsulting.com).
Lachman Consultants, Are You Using the New FDA Form 356h, September 2023 (lachmanconsultants.com).
Foley and Lardner, FDA Updates to Forms 356h and 1571 (foley.com).
University of Rochester Clinical and Translational Science Institute, guides on Form FDA 1571 updates (urmc.rochester.edu).
Code of Federal Regulations, Title 21, Parts 312.23, 314.50, 314.94 and 601.2 (ecfr.gov).