Preparing Regulatory Submissions with the FDA Reviewer in Mind: Use of the Clinical Review Template and Clinical Safety Reviewer Guidance by Sponsors

Abstract

Both the guidance documents issued by FDA to industry and the guidance documents intended to be used internally by FDA's own staff of medical review officers (MROs) can be effective tools to help sponsors prepare their regulatory submissions. Two recent reviewer guidance documents, the clinical review template and the corresponding guidance, “Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review,” provide useful insight into the FDA review process. The review of the clinical data has always been on the critical path to market approval for new molecular entities, and the recent reauthorization of the Prescription Drug User Fee Act (PDUFA IV) has underscored both the importance of an efficient review and postmarketing safety monitoring. The more FDA and the sponsors harmonize their efforts, with sponsors providing the summaries and analyses (including comprehensive tables, figures, and listings) that MROs need to adequately assess the safety data and document their reviews, the greater the opportunity for FDA to meet the performance goals set out in PDUFA and for FDA and industry together to deliver safe and effective new therapies to US patients in a timely fashion.