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What should a voluntary approval-withdrawal or biologic-license revocation request establish?
Identify the exact approval or license, products affected, factual basis and authorized scope. Review the applicable provision and hearing consequences before execution. Reconcile remaining supply, pending supplements, commitments and any transfer with the responsible owners. Retain the agency’s actual disposition separately from the request; they establish different events.
Before you begin
Approved NDA/ANDA withdrawal and biologic license revocation. Contested agency enforcement actions require their own procedural response.
What you will prepare: A legally reviewed request with explicit scope and no unsupported assertion that approval has already ended.
For NDA/ANDA approvals, identify the exact withdrawal basis
Section 314.150(c) addresses an applicant’s request where the drug is no longer marketed and the specified conditions in paragraphs (a) and (b) do not apply. A written request under that paragraph is treated as waiver of the otherwise available hearing opportunity. Do not insert hearing-waiver language casually or represent this route as appropriate when unresolved safety or effectiveness grounds change the analysis.
Have authorized legal/regulatory owners identify the application, products, approval history, actual marketing status and intended scope. A withdrawal request for one application does not establish the disposition of related applications, pending supplements or distinct products.
For biologics, distinguish voluntary revocation and transfer
Section 601.5(a) addresses a manufacturer’s application to revoke a license on notice of intended discontinuation of all products or a particular licensed product and waiver of a hearing. CBER SOPP 8403 describes its administrative processing, including coordination where a product transfers to a new applicant. Revocation associated with a transfer should not inadvertently interrupt the intended licensing arrangement.
State the license/application identity, affected products, factual reason, requested action and authorized commitments. Confirm center-specific routing. Keep a request, an agency acknowledgement and the actual agency action as separate records; a signed letter is not itself proof of revocation.
Worked check: a shared license covers several products
Fictional exercise: a company discontinues one biologic but holds other licensed products. The draft asks to revoke the entire U.S. license without defining the product scope. Compare the license record and business decision, then obtain an explicit legal/regulatory determination of the requested scope before signing.
For either pathway, assess supply, remaining inventory, safety reporting, record retention and communications with the relevant owners. The withdrawal document should not promise that all obligations cease merely because the company stops selling the product.
Review inventory and pending supplements before the final request
Build a product-level record before describing the entire application or license as ready for withdrawal or revocation. The internal worksheet below helps regulatory, quality, supply and legal owners review the same scope.
| Decision | Evidence to reconcile | Consequence to resolve |
|---|---|---|
| Whole license or individual product | License number, BLA/product records and authorized decision | Avoid unintentionally including other licensed products |
| Discontinuation or transfer | Receiving applicant and proposed action, if any | Coordinate the licensing and revocation actions for a transfer |
| Remaining inventory | Distributed lots, circulation status and expiry information | Confirm the relevant center’s inventory treatment |
| Pending supplements | Supplement list and whether changes affect distributed product | Determine appropriate withdrawal or other disposition |
| Commitments and requirements | Current list and agency correspondence | Obtain the actual product office disposition rather than assuming release |
| Final status | Agency action and effective date | Update operational records from the disposition, not the draft request |
For CBER-regulated products, SOPP 8403 version 6, §V.H, addresses remaining distributed product and generally considers expiry before voluntary revocation, while recognizing possible cell and gene therapy exceptions. It also addresses withdrawal of pending supplements. A supplement whose changes have already been implemented for distributed product cannot simply be grouped with unused proposals: the SOPP describes approval being needed unless all related distributed product is removed from circulation. Apply that distinction with the responsible product office; it is CBER’s staff procedure, not a blanket rule invented for all BLAs.
Implemented-change exercise: the revocation worklist contains two pending supplements. One proposes an unused manufacturing change; the other concerns a change already represented in distributed lots. A single request to withdraw both would hide a consequential difference. Reconcile lot history to each supplement and obtain the appropriate disposition before finalizing the request.
The same SOPP leaves the final treatment of postmarketing commitments and requirements to the product office based on the circumstances. Record that disposition explicitly. For a product transfer, §V.I coordinates licensing and revocation effective dates; use the ownership-transfer and license-reissuance guide. If the business intends only to stop selling an NDA/ANDA product, compare the withdrawal-from-sale guide before requesting withdrawal of approval.
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 a voluntary withdrawal request under §314.150(c) affect hearing rights?
Yes. That paragraph treats the written request as a waiver of the otherwise available hearing opportunity. Its route concerns a drug no longer marketed where the listed conditions in paragraphs (a) and (b) do not apply. Have authorized owners assess those facts and consequences before executing the request.
Must a company revoke every biologic product when it discontinues one?
No. Section 601.5(a) distinguishes discontinuing all products under a license from discontinuing a particular licensed product, and CBER’s procedure addresses individual-product revocation. Identify the exact product and license scope. A broad request should not inadvertently encompass other products the manufacturer intends to retain.
Can all pending BLA supplements be withdrawn together during revocation?
Do not assume so. CBER SOPP 8403 distinguishes supplements involving changes already implemented in distributed product. It describes approval being necessary for those supplements unless all related distributed product is removed from circulation. Reconcile supplement and lot records with the product office before grouping them into a withdrawal request.
Are postmarketing commitments and requirements automatically closed when revocation is requested?
No. A request is not an agency disposition. CBER SOPP 8403 also leaves the final determination about releasing product commitments and requirements upon revocation to the product office in light of the circumstances. Keep the current obligations assigned until their actual treatment has been established.
Sources and revisions
Requirements, source recommendations and editorial preparation advice have different roles. Review the scope and revision of the source you use.
Regulation
21 CFR Part 314: drug marketing applications ↗Current part reopened September 22, 2026; §§314.50, 314.53, 314.65, 314.72, 314.94, 314.99, 314.108 and 314.150–162 inspected. Not a general BLA rule.
Regulation
21 CFR Part 601: biologics licensing ↗Current part reopened September 22, 2026; §§601.5 and 601.9 distinguish revocation and reissuance.
FDA resource
CBER SOPP 8403: issuance, reissuance and voluntary revocation ↗Version 6, effective February 27, 2023; §V.C–G. CBER staff procedure, not an independent applicant regulation. PDF reopened September 22, 2026.
Technical specification · placement only
FDA eCTD v4.0 comprehensive hierarchy ↗Version 2.2, February 2025. Section 1.5.7. A heading identifies placement, not mandatory applicability.