Introduction/Background

The 505(b)(2) new drug application pathway offers unique advantages that can save sponsors significant time and money. Leveraging the 505(b)(2) process, our biotech customer achieved paper NDA approval for a parenteral acute-use drug.

While no new nonclinical studies were required for this approval, the FDA required a complete DART (development and reproductive toxicology) package and in vivo genotoxicity study within a short timeframe to meet Phase 4 post-marketing requirements. The sponsor needed to develop a successful approach to support the completion of post-marketing requirements under a tight timeline.

Solution

Premier Consulting selected nonclinical laboratories to run the multi-species genotoxicity program within the FDA’s agreed-upon timelines. In coordination with the nonclinical laboratory, Premier Consulting drafted the protocols and submitted them to the FDA for concurrence prior to initiating the studies. Due to significant delays with FDA protocol review and approval, the company worked with the nonclinical laboratory to further expedite the studies and still meet the original Phase 4 post-marketing timelines.

Premier Consulting served as the sponsor’s study monitor and coordinated all day-to-day activities, communications with the study director and principal investigators, data reviews, on-site study monitoring, draft report review, and report finalization.

Takeaway

When regulators identify gaps in your 505(b)(2) submission and approval rests on a timely response, experience matters. Choosing a team with the established know-how and relationships to efficiently execute any new study requirements can make the difference between sooner or later.

Outcome

All final reports were completed in accordance with the Phase 4 commitments.