The statistical analysis protocols (SAPs) for integrated
analyses of efficacy (ISE) and/or safety (ISS) are often submitted with the
briefing package for the pre-NDA meeting. If the pre-NDA meeting is held too
close to the intended submission date for the marketing application, the
sponsor is at risk to receive requests from FDA to modify the SAPs, without
adequate time to comply.
The impact of SAP modifications may be that additional
statistical programming is required, and that the timelines for programming,
the production and review of statistical outputs, and the authoring of clinical
summary documents, and draft labeling documents, are all extended.
Therefore, sponsors should consider preparing and submitting their
SAPs for the ISE and ISS for feedback sufficiently
in advance, to avoid putting the planned submission date for the marketing
application at risk.