Contacts in the Center for Biologics Evaluation & Research (CBER)
The FDA updated the official contact information and directory for the Center for Biologics Evaluation and Research (CBER).
This update affects manufacturers of biologics, vaccines, blood products, and cell/gene therapies, specifically their regulatory affairs and clinical operations teams who interface with CBER.
Maintaining accurate contact information within the Center is essential for ensuring timely correspondence and the proper routing of regulatory submissions. Even minor changes in organizational structure or contact points can lead to administrative delays in product reviews or compliance filings if not correctly addressed by industry stakeholders. This suggests an administrative refresh that firms should reflect in their own communication databases to avoid friction in agency interactions.
Regulatory teams should audit internal contact directories against the updated CBER list to ensure submissions and queries are routed to the current appropriate offices. Organizations should verify that communication protocols for time-sensitive reports (e.g., adverse events or biological product deviations) align with these updated contact points.
List of contact information in the Center for Biologics Evaluation & Research (CBER)
Open in openFDA / FDA.gov