Regulatory engagement with the U.S. Food and Drug Administration has become increasingly complex. As scientific innovation accelerates and novel modalities advance, regulatory expectations continue to evolve. At the same time, agency resource constraints, ambiguous guidance, and variable interpretation can create delays, inconsistent feedback, and added uncertainty across review cycles. Sponsors may experience mixed or shifting signals during development and review—challenges that can affect companies of all sizes, but which often place a disproportionate burden on small and emerging biotechnology companies with limited regulatory resources.

BIO is launching BIO BRIDGE to provide a structured, real-time mechanism to capture these experiences, translate them into evidence-based insights, and strengthen constructive engagement with FDA leadership.
 

Share Your Experience

BIO BRIDGE has opened a data collection effort to provide a real-time mechanism for participants to report FDA regulatory issues or roadblocks impacting the timely review and approval of innovative drugs or biologics regulated by FDA.

BIO BRIDGE will aggregate these anonymized experiences on major FDA issues and review them regularly for emerging trends. As patterns are identified, BIO will engage FDA leadership with evidence-based insights—providing visibility into areas of concern, enabling more efficient problem-solving, and working to mitigate future friction between sponsors and the agency.