Navigating Regulatory Challenges: A Collaborative Journey to FDA Approval

Puzzle pieces uncovering a seal of FDA approval

Case Study

Zachary Swan, PhD (Director, Regulatory Affairs)

Background and Challenge

Allucent was approached by a commercial-stage biopharmaceutical company focused on infectious diseases to provide writing and strategy support for their unique and complex New Drug Application (NDA) with multiple indications. The company faced a significant challenge when the FDA’s assessment deemed their initial studies in two similar proposed indications did not conform with new regulatory guidelines, which were newly introduced after the conduct of the studies. Based on the FDA’s feedback that the company focus on a single indication, the company understood that two new adequate and well-controlled studies for a single indication would be required. Alternatively, the FDA stipulated that a single study may be sufficient if another new study in a related patient population could be cross-supportive. 

Our Solution

Allucent’s priority in supporting this company was to construct a cohesive narrative explaining how the totality of clinical evidence from the new studies could support safety and effectiveness when combined with data from the earlier study that was completed prior to the revision of FDA guidelines. As such, Allucent began with the creation of a storyboard to ensure uniformity in messaging and strategy across all modules.  

Allucent proposed a single 2.7.3 section for each indication in lieu of a written Integrated Summary of Efficacy (ISE) and used thoughtful cross-referencing between Modules 2.5, 2.7.2, and 2.7.4 to avoid redundancy and present a clear, concise story of patient benefit. Data from the pivotal studies were incorporated into their respective 2.7.3 section, and Module 2.5 was utilized for a comparison and analyses of cross-study results instead of Section A discussion of clinical microbiology data across patient populations was integrated into Module Special Studies.   

For efficiency and consistency, the same writer responsible for drafting the pivotal study Clinical Study Report (CSR) authored the corresponding 2.7.3 section. A Lead Strategist was assigned to provide oversight to ensure harmony in messaging, data interpretation, and compliance with FDA guidance across the application. Allucent also provided valuable strategy input on the Integrated Summary of Safety Statistical Analysis Plan, mock Tables, Figures, and Listings, and pre-New Drug Application (NDA) meeting questions, supported the preparation of the Cardiac Safety Studies package to the FDA’s Integrated Review Team (IRT) for QT studies, and offered consultancy for Pediatric Written Requests.  


Our collaborative efforts yielded significant achievements for the company. The comprehensive solutions encompassed many facets of the regulatory landscape, from storyboard production to authoring pivotal study reports and more, ensuring a cohesive and compelling narrative that resonated with regulatory authorities.   

With Allucent’s strategic guidance and input, our client secured FDA’s agreement at the pre-NDA meeting on the approach to presenting the efficacy and safety data. This was a pivotal milestone that underscores Allucent’s proficiency in navigating regulatory negotiations. Subsequently, the client’s NDA was filed and shortly thereafter received approval for all indications, including pediatric patients. This achievement marked a significant milestone in the client’s journey, securing them 10 years of market exclusivity.  

The steadfast dedication of Allucent’s Regulatory A-team to problem-solving and relentless pursuit of excellence played a pivotal role in navigating regulatory hurdles. Our expertise was instrumental in devising innovative strategies that addressed the client’s immediate needs and laid the groundwork for long-term success. 

To read more on this topic, check out our blog, Strategizing for Your Submission: Planning Ahead for your NDA or BLA or contact us today to discuss how Allucent’s Regulatory Consulting experts can support your specific needs and help you achieve success with your product development program. 

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