---
title: "REF: IND Submission"
slug: "ref-ind-submission"
updated: 2026-08-05T14:06:17Z
published: 2026-08-05T14:06:17Z
canonical: "bgtcplaybook.document360.io/ref-ind-submission"
---

> ## 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.

# REF: IND Submission

## Module 1

1. Administrations, N. A. (2023, 04 14). Code of Federal Regulations. Retrieved from [https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-25?toc=1](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-25?toc=1)
2. CFR - Code of Federal Regulations Title 21. (2023, 03 28). Retrieved from U.S. Food & Drug Administration: [https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.23](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.23)
3. eCTD Resources. (2022, 12 13). Retrieved from U.S. Food & Drug Administration: [https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/ectd-resources](https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/ectd-resources)
4. Genetically Modified Organism (GMO) aspects for investigational medicinal products. (n.d.). Retrieved from European Commission: [https://health.ec.europa.eu/medicinal-products/advanced-therapies/genetically-modified-organism-gmo-aspects-investigational-medicinal-products_en](https://health.ec.europa.eu/medicinal-products/advanced-therapies/genetically-modified-organism-gmo-aspects-investigational-medicinal-products_en)

BGTC Regulatory Playbook Version 1.0 Page 74
5. Investigational New Drug (IND) Application. (2022, 07 20). Retrieved from U.S. Food & Drug Administration – [https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application](https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application)
6. Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators. (2015, May). Retrieved from U.S. Food & Drug Administration: [https://www.fda.gov/regulatory-information/search-fda-guidance-documents/investigational-new-drug-applications-prepared-and-submitted-sponsor-investigatorsE6(R2)](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/investigational-new-drug-applications-prepared-and-submitted-sponsor-investigatorsE6(R2)) Good Clinical Practice: Integrated Addendum to ICH E6 (R1). (2018, March). Retrieved from U.S. Food & Drug Administration: [https://www.fda.gov/media/93884/download](https://www.fda.gov/media/93884/download)

## Module 2

1. M4E(R2): The CTD – Efficacy. (2017, Retrieved from U.S. Food & Drug Administration: [https://www.fda.gov/regulatory-information/search-fda-guidance-documents/m4er2-ctd-efficacy](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/m4er2-ctd-efficacy)

2. M4S: The CTD — Safety. Retrieved from U.S. Food & Drug Administration: [https://www.fda.gov/regulatory-information/search-fda-guidance-documents/m4s-ctd-safety](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/m4s-ctd-safety)

## Module 3

1. Administration, U. F. (January 2020). Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs). Retrieved from [https://www.fda.gov/media/113760/download](https://www.fda.gov/media/113760/download)
2. Beginner’s guide to the production of AAV vectors for gene therapy – Mentored by a CDMO: [Guide to the production of AAV vectors for gene therapy - Biovian](https://biovian.com/news/beginners-guide-to-the-production-of-aav-vectors-for-gene-therapy-mentored-by-a-cdmo/)
3. 21 CFR Part 211
4. 21 CFR Part 600. Retrieved from [https://www.ecfr.gov/current/title-21/part-600](https://www.ecfr.gov/current/title-21/part-600)
5. Guidance for Industry CGMP for Phase 1 Investigational Drugs, July 2008. Retrieved from [https://www.fda.gov/media/70975/download](https://www.fda.gov/media/70975/download)
6. [Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations, September 2006](https://www.fda.gov/media/70975/download)
7. [Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations | FDA](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quality-systems-approach-pharmaceutical-current-good-manufacturing-practice-regulations)
8. U.S. Food and Drug Administration. Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs): [Guidance for Industry. U.S. Department of Health and Human Services](https://www.fda.gov/media/113760/download), Jan. 2020
9. U.S. Food and Drug Administration. Preclinical Assessment of Investigational Cellular and Gene Therapy Products: Guidance for Industry. U.S. Department of Health and Human Services, Nov. 2013, [Preclinical Assessment of Investigational Cellular and Gene Therapy Products](https://www.fda.gov/media/87564/download)
10. Ricles, Laura. U.S. FDA’s Perspective on Delivery Devices Used to Administer Cell and Gene Therapy Products. CASSS Cell & Gene Therapy Products (CGTP): Manufacturing, Quality, and Regulatory Considerations, 27 June 2023, U.S. Food and Drug Administration, [https://www.casss.org/docs/default-source/cgtp/2023-speaker-presentations/ricles-laura-fda-2023.pdf](https://www.casss.org/docs/default-source/cgtp/2023-speaker-presentations/ricles-laura-fda-2023.pdf)

## Module 4

1. Administration, U. F. (2022, November 08). Study Data for Submission to CDER and CBER. Retrieved from [https://www.fda.gov/industry/study-data-standards-resources/study-data-submission-cder-and-cber](https://www.fda.gov/industry/study-data-standards-resources/study-data-submission-cder-and-cber)

## Module 5

1. E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6 (R1). (2018, March). Retrieved from U.S. Food & Drug Administration: [https://www.fda.gov/media/93884/download](https://www.fda.gov/media/93884/download)
2. Forms. (2023, 4 19). Retrieved from U.S. Food & Drug Administration: [https://www.fda.gov/about-fda/reports-manuals-forms/forms](https://www.fda.gov/about-fda/reports-manuals-forms/forms)