User Interface Does Not Support Safe and Effective Use (Human Factors)
Severity: criticalThe Human Factors validation study revealed several use errors/close calls/use difficulties with critical tasks, potentially leading to patient harm or compromised efficacy. Risks include underdose, overdose, inadvertent exposure to others, and associated adverse events (e.g., local site reaction, mydriasis, blurred vision, dry mouth, urinary hesitation). Additional risk mitigations and design modifications are required.
Recommended response: Review HF study results and subjective feedback to identify optimization areas. Implement additional design modifications (e.g., label applicator, revise IFU content/format, add handwashing statement to principal display panel). Consider mitigation for applicator tilting/spilling. Conduct another HF validation study to demonstrate safe and effective use.
Incomplete Safety Update
Severity: majorA comprehensive safety update is required as described at 21 CFR 314.50(d)(5)(vi)(b). This includes detailed changes in the safety profile, new safety data from all nonclinical and clinical studies/trials (for proposed and other indications), retabulation of discontinuation reasons, case report forms/narrative summaries for deaths/serious adverse events, information on changes in common adverse events, updated exposure information, worldwide safety experience, and English translations of current approved foreign labeling.
Recommended response: Provide a comprehensive safety update including all requested data elements as per 21 CFR 314.50(d)(5)(vi)(b), covering nonclinical and clinical studies, worldwide experience, and foreign labeling translations.
Cited: 21 CFR 314.50(d)(5)(vi)(b)
Proprietary Name Resubmission Required
Severity: minorThe proposed proprietary name, Sofdra, was found acceptable pending approval of the application. It must be resubmitted when responding to the application deficiencies.
Recommended response: Resubmit the proposed proprietary name (Sofdra) with the response to deficiencies.
Labeling Comments Reserved
Severity: infoComments on the proposed Prescribing Information, Carton, and Container Labeling are reserved until the application is otherwise adequate. The sponsor is encouraged to review FDA labeling resources and use the SRPI checklist for format compliance.
Recommended response: Review FDA labeling resources and the SRPI checklist. Update content of labeling in SPL format when resubmitting the application.
