Center for Biologics Evaluation and Research Patient Engagement Program
Patient input is a critical part of CBER’s understanding of diseases and conditions. Engaging with patients and listening to their perspectives on t…
Category: US National Health Agency Sources
Update: COVID-19 Vaccine Booster Composition
FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) held a virtual meeting on June 28, 2022, to publicly discuss whether a ch…
Patients assemble for very special story hour
Patients at the Spinal Cord Injury and Disorders Center at Jefferson Barracks VA assembled recently for a very special story hour.
FDA Roundup: March 21, 2025
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Recently Issued Guidance Documents
This page lists Recently Issued CBER and Cross-Center Guidance Documents.
Antimicrobial Resistance
Antimicrobial resistance (AMR)—the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the effects of a drug—is a serious, com…
Developing a Toolkit to Assess Efficacy of Ebola Vaccines and Therapeutics
MCMi regulatory science project to research issues that are key to understanding and predicting if—and how—vaccines and therapeutics to prevent an…
Guidance and Other Information of Special Interest to MCM Stakeholders
Information of particular interest to sponsors/applicants of medical countermeasures to treat, prevent, diagnose, and detect chemical, biological, rad…
Cleared 510(k) Submissions with Supporting Documents
Listing of cleared 510(k) submissions with supporting documents. Information is reflected as of the clearance date.