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Clinical and Regulatory Strategy: FDA Approval Process


A start-up biopharmaceutical company with no marketed drugs was trying to get its first product through the FDA approval process and to market.  The product used an “improved” delivery system to obtain higher systemic doses to treat a very rare cancer with a short median survival overall rate.  Due to the small patient population, comparative trials were not pursued.  The trial results appeared positive, yet the lack of comparative data created uncertainty with the interpretation of efficacy and safety.


3D worked with the client to develop an FDA approval strategy that put the treatment’s clinically meaningful benefit in context by comparing it to a defined historical control.  We collaborated with the team to conduct a comprehensive assessment of adverse events to demonstrate relative safety and define potential safety signals.  We then augmented the integrated summaries in the FDA submission documents to proactively address FDA comments and issues and align the product with precedent. This strategy was refined in the advisory committee meeting preparation, emphasizing the empirical analyses that supported benefit-risk and proposing post-approval commitments to resolve lingering uncertainty.


The advisory committee voted in favor of approval, and the FDA approved the treatment months later.

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