Share Your Experience

Given the current state of a rapidly evolving scientific and regulatory ecosystem, it is critical to have a real-time understanding of any shifts in regulatory predictability, efficiency, or regulator expectations. To address this gap, BIO is introducing BRIDGE (BIO Regulatory Issue Data Gathering & Exchange) to move from anecdotal feedback to a more structured data-collection framework capturing member-reported data on regulatory issues/roadblocks impacting the timely review and approval of an innovative drug or biologic regulated by the FDA. Through BRIDGE, BIO will systematically aggregate member data, identify trend-level regulatory challenges, and engage FDA as needed to improve visibility into areas of recurring friction.

BRIDGE is intentionally structured as a learning and quality-improvement mechanism, not an advocacy or escalation tool. By converting isolated regulatory questions into aggregated, actionable intelligence to guide BIO’s engagement with FDA, the program can strengthen understanding across the ecosystem and enable BIO to engage in constructive problem solving with FDA. 

Antitrust Compliance
BRIDGE has been designed to prevent the sharing or reporting of individual company responses and competitively sensitive information. All company-specific information will be aggregated, pursuant to procedures developed with legal counsel, before being shared externally (i.e., before being reported to FDA).  The collected information will not be shared back to members.

BRIDGE is a time-limited initiative. Upon winding down, any and all company-specific information still in BIO’s possession will be destroyed.