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  1. Center for Drug Evaluation and Research (CDER)

Other Meeting Options Related to Human Drugs

This table lists established meeting request processes for different types of meeting options related to human drugs. Use the filters and search boxes to find meeting options. For more information, contact CDER Professional Affairs and Stakeholder Engagement at CDERPASE@fda.hhs.gov.

Filter by Stakeholder Type and Meeting Topic

Human drug products topic = prescription, over-the-counter, nonprescription, and therapeutic biologics
Cross-center topic = spanning topics related to drugs, devices, biologics, vaccines, blood components, cosmetics, tobacco, dietary supplements, cannabis, or veterinary medicine

Stakeholder Type Topic More Information
Patient group, Patient advocacy organization Patient Engagement, Cross-center Learn about FDA Patient Engagement
Patient group, Patient advocacy organization Patient Engagement, Cross-center Learn about the Patient Engagement Collaborative
Patient group, Patient advocacy organization Patient Engagement, Cross-center Learn about the FDA Patient Representative Program
Patient group, Patient advocacy organization, Health care professional organization Patient Engagement, Cross-center Submit a Meeting Request to FDA’s Public Engagement Staff
Patient group, Patient advocacy organization Patient Engagement Follow the procedure for requesting a Patient Listening Session Meeting
Patient group, Patient advocacy organization Cancer/Oncology Learn more at Project Community
Patient group, Patient advocacy organization Patient-Focused Drug Development Follow the procedure for conducting an Externally-Led Patient-Focused Drug Development Meeting
Industry sponsor New drug development Follow the procedure for Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
Industry sponsor Complex generic drug development Follow the procedure for Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA
Industry sponsor Pre-investigational new drug application Review Frequently Asked Questions on the Pre-IND Meeting
Industry sponsor Novel products and development programs, Pre-investigational new drug application Follow the procedure for Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products to request an INTERACT meeting
Industry professional organization, Consortia Investigational new drug applications, New drug development, Complex generic drug development, Human drug products, Cancer/Oncology Register for an upcoming conference hosted by CDER Small Business and Industry Assistance
Patient Group, Patient advocacy group, Professional organization, Other non-sponsor group, Academia, Health care professional organization, Charitable foundation, Global organization, Service provider, Other government agency, Industry professional organization, Consortia, General public Human drug products Follow the procedure to Request a Meeting on Drugs through Professional Affairs and Stakeholder Engagement (PASE) Staff
Patient group, Patient advocacy organization, Industry sponsor, Industry professional organization, Consortia, Professional organization, Other non-sponsor group, Academia, Other government agency Methodology or technology to advance drug development Follow the procedure for Critical Path Innovation Meetings (CPIM)
Industry sponsor, Industry professional organization, Consortia, Industry professional organization, Other non-sponsor group, Health care professional organization, Charitable foundation, Academia, Global organization, Service provider, Other government agency Methodology or technology to advance drug development Follow the procedure for Drug Development Tools including Digital Health Technologies, Decentralized Clinical Trials
Patient group, Patient advocacy organization, Industry sponsor, Industry professional organization, Consortia, Professional organization, Other non-sponsor group, Academia, Charitable foundation, Health care professional organization, Global organization, Service provider, Other government agency Speech, presentation, or participation in an external event, Human drug products To request a CDER speaker for an external event, follow the procedure for the Speaker Request Form
Patient group, Patient advocacy organization, Industry sponsor, Industry professional organization, Consortia, Professional organization, Other non-sponsor group, Academia, Global organization, Charitable foundation, Health care professional organization, Service provider, Other government agency Public Private Partnership, Consortium Learn more about Engagement with Public Private Partnerships and Consortia
Patient group, Patient advocacy organization, Industry sponsor, Industry professional organization, Consortia, Professional organization, Other non-sponsor group, Academia, Charitable foundation, Health care professional organization, Global organization, Service provider, Other government agency, General public Human drug products, Cross-center, Cancer/Oncology, Patient Engagement, New drug development, Novel products and development programs Learn more about Advisory Committee meetings
Patient group, Patient advocacy organization, Industry sponsor, Industry professional organization, Consortia, Professional organization, Global organization, Other non-sponsor group, Academia, Charitable foundation, Health care professional organization, Service provider, Other government agency, General public Human drug products, Cross-center, Cancer/Oncology, Patient Engagement, Methodology or technology to advance drug development, New drug development, Complex generic drug development, Pre-investigational new drug application, Novel products and development programs Attend a public meeting involving FDA

To ask a question related to human drugs, visit CDER Contact Information.

To ask a question to another center or office, visit Contact FDA.

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