Emerging Drug Safety Technology Meetings (EDSTM)
CDER has established a meeting program called the Emerging Drug Safety Technology Meeting (EDSTM) program. Learn more.
FDA Compounding Documents and Actions
Find descriptions of some of the documents and actions, such as warning letters, recalls, Form 483 and inspection warrant, involved…
Nana Barseghian, M.D./Amicis Research Center – 708009 – 04/28/2025
Clinical Investigator
Surface Wipe Sampling of Hazardous Medicinal Products: A European Interlaboratory Comparison Study
This study aimed to conduct an interlaboratory comparison (ILC) program to evaluate the performance of European laboratories in detecting hazardous…
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…