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  1. Center for Drug Evaluation and Research (CDER)

Other FDA Meeting Options

Purpose for Meeting How to Submit Meeting Request to FDA
General information regarding the use or feasibility of digital health technologies and/or the implementation of decentralized elements in clinical trials to support the development of drug or biological products Follow the procedure for Stakeholder Engagement
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
Critical Path Innovation Meetings (CPIM)

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
 
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