User Interface Design Does Not Support Safe and Effective Use
Severity: criticalThe human factors (HF) validation study revealed that the user interface does not support safe and effective use. Participants failed to depress the plunger, with some believing a dose was administered when it was not, due to early clicking sounds and plunger counterpressure. This could lead to no dose administration, negatively impacting patient care and potentially increasing mortality risk. The agency requires user interface revisions, design modifications, and data demonstrating safe and effective use, along with submission of a revised HF validation study protocol.
Recommended response: Implement user interface revisions and design modifications to promote safe and effective use. Provide data demonstrating the revised product's safe and effective delivery of the intended dose. Submit the HF validation study protocol and redesigned user interface for review prior to conducting the assessment.
Inadequate Safety Update
Severity: majorA comprehensive safety update is required as described at 21 CFR 314.50(d)(5)(vi)(b). This includes detailing significant changes in the safety profile, presenting new and combined safety data from clinical trials (including for other indications), providing case report forms and narrative summaries for deaths and serious adverse events, updating exposure information, and summarizing worldwide safety experience.
Recommended response: Provide a complete safety update in accordance with 21 CFR 314.50(d)(5)(vi)(b), including all requested data, tabulations, narratives, and worldwide experience summaries.
Cited: 21 CFR 314.50(d)(5)(vi)(b)
Prescribing Information Comments Reserved
Severity: infoThe FDA reserves comment on the proposed prescribing information until the application is otherwise adequate. The sponsor is encouraged to review labeling review resources, regulations, and guidance documents.
Recommended response: Address primary deficiencies first. Review FDA's Prescription Drug Labeling Resources and Pregnancy and Lactation Labeling Final Rule websites for guidance on labeling requirements.
Carton and Container Labeling Comments Reserved
Severity: infoThe FDA reserves comment on the proposed carton and container labeling until the application is otherwise adequate.
Recommended response: Address primary deficiencies first. Ensure carton and container labeling will comply with regulations once the product is deemed approvable.
