Other FDA Meeting Options
Purpose for Meeting | How to Submit Meeting Request to FDA |
---|---|
Request Center for Drug Evaluation and Research (CDER) staff members to give a speech, presentation, or participate on a panel, meeting, or webinar related to CDER regulations, policies, and initiatives | Follow the procedure for the Speaker Request Form |
Conduct an off-site Externally-Led Patient-Focused Drug Development meeting |
Follow the procedure for conducting an Externally-Led Patient-Focused Drug Development Meeting |
Ask questions about drug safety information, label changes, and shortages |
Contact Drug Safety and Availability |
Find information about expanded access for investigational drugs and biologics |
Physicians: Request Single-Patient Expanded Access Patients: Expanded Access Information for Patients |
The CPIM is a forum for FDA and investigators from industry, academia, patient advocacy groups, consortium, and other government agencies to communicate to improve efficiency and success in drug development. The goal of the CPIM is to discuss a methodology or technology proposed by the meeting requester and for CDER to provide general advice on how this methodology or technology might enhance drug development. |
Follow the procedure for |
Submit a Clinical Outcome Assessment (COA) tool for qualification | Follow the procedure for the COA Qualification Program |
Submit a biomarker for qualification | Follow the procedure for the Biomarker Qualification Program |
Discuss human drug compounding with CDER | Contact the Pharmacy Compounding Advisory Committee |
Request a meeting about blood, vaccines, or other biologics |
Contact the Center for Biologics Evaluation and Research (CBER) Office of Communication, Outreach, and Development |