Resources - Official FDA Submissions and Responses

INTERACT meeting

CHED-INTERACT-Briefing Package

CHED-INTERACT- Preliminary Responses From FDA

Pre-IND meeting

MSD Pre-IND Meeting - Briefing Package

MSD Pre-IND meeting - FDA Meeting Summary

MSD Pre-IND Meeting - Follow-up CMC Questions

MSD Pre-IND Meeting - Follow-up CMC Questions - FDA Responses

Orphan Drug Designation (ODD) applications

CHED ODD application

CMT4J-ODD application

CNGB1 ODD application

MPS IVA ODD application

MSD ODD application

NPHS ODD application

PA PCCB ODD application

Rare Pediatric Disease Designation (RPDD) applications

CHED RPDD application

CMT4J RPDD application

CNGB1 RPDD application

MPS IVA RPDD application

MSD RPDD application

NPHS RPDD application

PA PCCB RPDD application