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Rapid Nonclinical Planning and Coordination Keep Post-Marketing Requirements on Track

Challenge: A sponsor needed support completing post-marketing requirements under a tight timeline.


Background

Leveraging the 505(b)(2) pathway, a biotech company 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 package and in vivo genotoxicity study within a short timeframe to meet Phase 4 post-marketing requirements.

 
 

Solution

Camargo selected CROs to run the multi-species genotoxicity program, within the FDA’s agreed upon timelines. In coordination with the CRO, Camargo 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, Camargo worked with the CRO to further expedite the studies and still meet the original Phase 4 post-marketing timelines. Camargo 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.

 
 

Outcome

Under Camargo’s oversight, all final reports were completed in accordance with the Phase 4 commitments.