---
title: "Resources - Official FDA Submissions and Responses"
slug: "resources-official-fda-submissions-and-responses"
updated: 2025-05-19T22:33:41Z
published: 2025-05-19T22:33:41Z
canonical: "bgtcplaybook.document360.io/resources-official-fda-submissions-and-responses"
---

> ## Documentation Index
> Fetch the complete documentation index at: https://bgtcplaybook.document360.io/llms.txt
> Use this file to discover all available pages before exploring further.

# Resources - Official FDA Submissions and Responses

## INTERACT meeting

[CHED-INTERACT-Briefing Package](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/CHED-INTERACT-Briefing%20Package_Redacted_Disclaimer.pdf)

[CHED-INTERACT- Preliminary Responses From FDA](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/CHED-INTERACT-Preliminary%20Responses%20From%20FDA_Redacted_Disclaimer.pdf)

## Pre-IND meeting

[MSD Pre-IND Meeting - Briefing Package](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/MSD_pre-IND%20Meeting_Briefing%20Package_Redacted_25Mar2025_Redacted.pdf)

[MSD Pre-IND meeting - FDA Meeting Summary](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/MSD_pre-IND%20Meeting_FDA%20Meeting%20Summary_Redacted_25Mar2025_Redacted.pdf)

[MSD Pre-IND Meeting - Follow-up CMC Questions](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/MSD_pre-IND%20Meeting%20Follow-up%20CMC%20Questions_Redacted.pdf)

[MSD Pre-IND Meeting - Follow-up CMC Questions - FDA Responses](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/MSD_pre-IND%20Meeting%20Follow-up%20CMC%20Questions_FDA%20Responses_Redacted.pdf)

## Orphan Drug Designation (ODD) applications

[CHED ODD application](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/CHED%20ODD%20Request_Redacted_Redacted%20Disclaimer.pdf)

[CMT4J-ODD application](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/CMT4J-ODD-31Jul2024_Redacted%20Disclaimer.pdf)

[CNGB1 ODD application](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/CNGB1%20ODD%20Request_Redacted%20MW_Redacted%20Disclaimer.pdf)

[MPS IVA ODD application](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/MPS%20IVA%20ODD%20Request_Redacted%20MW_Redacted%20Disclaimer.pdf)

[MSD ODD application](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/MSD%20ODD%20Request_Redacted%20MW_Redacted%20Disclaimer.pdf)

[NPHS ODD application](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/NPHP5%20ODD%20Request_Redacted%20MW_Redacted%20Disclaimer.pdf)

[PA PCCB ODD application](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/PA%20PCCB%20ODD%20Request_Redacted%20Disclaimer.pdf)

## Rare Pediatric Disease Designation (RPDD) applications

[CHED RPDD application](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/CHED%20RPDD%20Request_Redacted_%20Redacted%20Disclaimer.pdf)

[CMT4J RPDD application](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/CMT4J-RPDD-31Jul2024_Redacted%20Disclaimer.pdf)

[CNGB1 RPDD application](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/CNGB1%20RPDD%20Request_Redacted%20MW_%20Redacted%20Disclaimer.pdf)

[MPS IVA RPDD application](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/MPS%20IVA%20RPDD%20Request_Redacted%20MW_Redacted%20Disclaimer.pdf)

[MSD RPDD application](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/MSD%20RPDD%20Request_Redacted%20MW_Redacted%20Disclaimer.pdf)

[NPHS RPDD application](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/NPHP5%20RPDD%20Request_Redacted%20MW_Redacted%20Disclaimer.pdf)

[PA PCCB RPDD application](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/PA%20PCCB%20RPDD%20Request_Redacted%20Disclaimer.pdf)