FDA Milestones meetings – Type B

Published by IRDiRC

Early Access Support End of Phase 2 Meeting Milestone Meeting Pre-NDA Meeting Regulatory Advice Regulatory Affairs Scientific Advice

The default drug development program includes three milestones, or Type B meetings. The earliest is the Pre-IND Meeting, the second is the End of Phase 2 (EOP2) Meeting, and the third milestone is the Pre-NDA Meeting.

View this resource Bookmark this resource

Pre Investigational New Drug (IND) interactions

Published by IRDiRC

Early Access Support Milestone Meeting Pre Investigational New Drug Interaction Pre-NDA Meeting Regulatory Affairs Scientific Advice

A pre-IND meeting is an FDA milestone meeting also known as Type B meeting . In these meetings the drug sponsor seeks FDA feedback about the quality, non- clinical and clinical development plan. The Pre-IND meetings are not mandatory.

View this resource Bookmark this resource

The Innovation Management Toolbox was originally developed through funding from the EJP RD project, which received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 825575. The continued development and maintenance of the Toolbox are now supported by the ERDERA partnership, funded under the European Union’s Horizon Europe Research & Innovation programme, grant agreement No. 101156595.

IMT Feedback

Did the IMT help you in finding the resource you needed?

FDA Milestones meetings – Type B

Pre Investigational New Drug (IND) interactions