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 organization; Industry professional organization; Consortia; Professional organization; Academia; Global organization; Charitable foundation; Health care professional organization; Service provider; Other government agency; General public; Other non-sponsor group |
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 |
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