On This Page Date: May 6, 2025 [embedded content] Visit CDER Small Business and Industry Assistance (SBIA) Homepage About this Event (Hosted by CDER SBIA) The […]

On This Page Date: May 20, 2025 Time: 1:00 p.m. – 2:00 p.m. ET Visit CDER Small Business and Industry Assistance (SBIA) Homepage About this Event […]

On This Page Date: May 22, 2025 Time: 10:00 a.m. – 4:00 p.m. ET On May 22, the Reagan-Udall Foundation for the FDA, in collaboration with […]

Image Please follow these steps to request an FDA patient-led listening session: Complete the Patients Ask FDA webform. Enter the information request, including: The health condition, […]

Image Download PDF Print Version Helpful Information: FDA Patient Listening Sessions are one way for the patient community to share perspectives with the FDA about their […]

Image Planning for an FDA patient-led listening session typically takes four to six months. After the Patient Listening Session has been scheduled, the patient(s)/organization who requested […]

Image FDA Patient Listening Sessions are short meetings that last up to 90 minutes.  During the FDA Patient Listening Session, it is important to focus on […]

Docket Number: FDA-2020-D-1370 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research The Food and Drug Administration (FDA […]

Background The Standard Safety Tables and Figures (ST&F) are designed to reduce clinical reviewers’ time in generating safety review content and to ensure consistency in the […]