CDER Bioresearch Monitoring: Electronic Submission Requirements for New Drug and Biologic Licensing Applications – 05/06/2025
CDER Bioresearch Monitoring: Electronic Submission Requirements for New Drug and Biologic Licensing Applications
OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2025 User Fees and Registration – 05/20/2025
OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2025 User Fees and Registration
Primary Mitochondrial Diseases Virtual Public Workshop – 05/22/2025
Primary Mitochondrial Diseases Virtual Public Workshop
CDER Quality Management Maturity
FDA has proposed the development of a rating system that will help incentivize drug manufacturers to achieve Quality Mangement Maturity…
Bioresearch Monitoring Information System (BMIS)
Bioresearch Monitoring Information System (BMIS) background page with download file.
Patient Listening Session Summaries
Patient Listening Session summaries are published after each session to share a high-level summary of the discussion. The Public Engagement…
Requesting an FDA Patient-Led Listening Session
Learn about how to request a Patient Listening Session with the FDA to share your experiences and perspectives.
Suggested Sample Agenda for an FDA Patient-Led Listening Session
View a suggested sample agenda an FDA Patient-Led Listening Session
Planning an FDA Patient-Led Listening Session
Learn the steps for planning an FDA Patient-Led Listening Session.
Preparing Patient and Caregiver Participants for an FDA Patient-Led Listening Session and Suggested Topics
Learn about topics that are outside of the scope of FDA’s work and suggested topics for FDA-Patient-Led Listening Sessions.