Write the ANDA basis for submission statement

What belongs in an ANDA basis for submission statement?

Identify the reference listed drug by name, dosage form and strength; address its listed marketing-exclusivity status; and, for a petitioned ANDA, include the petition docket and FDA approval correspondence. Separately support the proposed conditions of use with the annotated labeling references. Identify the FDA-selected reference standard for BE studies without confusing it with the RLD.

Before you begin

ANDA basis and conditions-of-use statements under 314.94(a)(3)–(4); not an NDA 505(b)(2) reliance rationale.

What you will prepare: A basis statement whose identifiers and regulatory references agree with the proposed generic product.

Identify the RLD separately from the study comparator

Collect the current FDA listing, RLD name, application/product identifier, strength, dosage form, route and approved labeling. Separately identify the FDA-selected reference standard used for any required in-vivo bioequivalence work. The RLD is the regulatory reference for the application; the selected study comparator may differ.

Use the current authoritative listing and agency correspondence, with the date checked in the working record. A purchase order for comparator supply is evidence of what was bought, not proof that the chosen product is the correct RLD.

Write the basis and conditions of use in distinct paragraphs

Under 314.94(a)(3), identify the RLD including dosage form and strength, address the specified marketing-exclusivity information, and provide the approved suitability-petition reference and FDA approval correspondence when the ANDA relies on such a petition. Under (a)(4), address conditions of use and reference the annotated proposed labeling and current RLD labeling.

An editorial evidence table should connect each basis assertion to the FDA listing, labeling passage or petition record. For a petitioned ANDA, confirm that the RLD and permitted difference match the approved petition; a petition request still awaiting action is not an approval letter. Have the responsible owner assess any omission or permitted labeling difference rather than describing all proposed uses as identical by default.

Worked review: the purchased comparator is not the RLD

Fictional editorial exercise: FDA identifies a generic product as the reference standard because the RLD is not marketed. The draft basis statement names that generic product as the RLD solely because it supplied the BE comparator.

Correct the roles using the FDA records and reconcile the statement with the BE report. If the reference designation is uncertain, obtain clarification before making a categorical claim. Change the proposed dosage form: reassess whether the intended ANDA basis remains available instead of assuming a similarity table establishes eligibility.

Build a short statement from a controlled reference record

Use one reference record across the application form, basis statement, product comparison, labeling and BE package. Each document has its own purpose, but the same product must not acquire different identities as the submission moves between teams.

An effective first paragraph identifies the application and the RLD. A second addresses the exclusivity information required by 314.94(a)(3)(ii). A petitioned application then identifies the docket, approved difference and approval correspondence. The conditions-of-use statement belongs with an explicit reference to the labeling evidence under (a)(4). These are drafting components, not a prescribed sentence template or a certification of unknown product facts.

Keep the marketing-exclusivity statement distinct from the patent certifications required elsewhere in the ANDA. A completed basis paragraph does not dispose of every intellectual-property issue or establish when FDA may approve the application. Have the responsible owner reconcile those analyses without inserting an unsupported approval date.

Fictional cross-document review: the basis statement identifies Product A as the RLD, the BE report correctly identifies FDA-selected Product B as the reference standard, and the labeling author compares the proposed labeling against B. The presence of two product names is not itself the defect. The misplaced labeling comparison is. Preserve A as the regulatory reference, B as the study comparator, and correct the labeling evidence to the RLD. Do not “fix” consistency by changing every field to B.

If the RLD is in the Discontinued Section, inspect the status and any FDA safety/effectiveness withdrawal determination. The October 2020 guidance explains the petition requirement where that determination has not been published, including reference to a petition already pending. Discontinued marketing alone does not answer whether the drug was withdrawn for safety or effectiveness. Keep that determination and the availability of study supply as separate questions.

For each open discrepancy, record the disputed field, conflicting sources, owner and evidence needed to resolve it. Do not leave a generic “verify RLD” comment for the final publishing review. The final comparison should connect to the generic/RLD comparison and the BA/BE waiver rationale, if one is proposed.

Frequently asked questions

Sources and revisions

Requirements, source recommendations and editorial preparation advice have different roles. Review the scope and revision of the source you use.

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