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Required forms, legal basis flagged as common major deficiencies in Module 1
Summary
The presenter warned that omitting or failing to sign Form FDA 356h and lacking a legal basis for submission (e.g., differences from the RLD without an approved petition) are treated as major deficiencies and can prompt an RTR or withdrawal request.
The agency official highlighted Module 1 requirements and cautioned that "Form FDA 3 56 h is a required form. It should be signed and completed. If this form is omitted or unsigned, then it is a major deficiency." He noted that foreign applicants need a designated U.S. agent and that agent should countersign the form.
The presenter also said a lack of legal basis — for example when a proposed product differs from the reference listed drug (RLD) without an approved certificate petition and supporting docket/approval letter — is a major deficiency and may require withdrawing the ANDA or supplying the petition evidence up front.
