---
title: "REF: Pre-IND Meeting"
slug: "ref-pre-ind-meeting"
updated: 2026-10-27T14:27:14Z
published: 2026-10-27T14:27:14Z
canonical: "bgtcplaybook.document360.io/ref-pre-ind-meeting"
---

> ## 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: Pre-IND Meeting

1. Learn about Pre-IND meetings. (n.d.). Retrieved March 4, 2023, from [https://toolkit.ncats.nih.gov/module/prepare-for-clinical-trials/participating-in-initial-meetings-with-regulators/learn-about-Pre-IND-meetings/](https://toolkit.ncats.nih.gov/module/prepare-for-clinical-trials/participating-in-initial-meetings-with-regulators/learn-about-Pre-IND-meetings/)
2. Center for Drug Evaluation and Research. (n.d.). Small Business and Industry Assistance: Frequently asked questions. Retrieved March, 2023, from [https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/small-business-and-industry-assistance-frequently-asked-questions-pre-investigational-new-drug-ind](https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/small-business-and-industry-assistance-frequently-asked-questions-pre-investigational-new-drug-ind)
3. (NCATS), N. C. (n.d.). NCATS Toolkit for Patient-Focused Therapy Development. Retrieved from Learn about Pre-IND Meetings: [https://toolkit.ncats.nih.gov/module/prepare-for-clinical-trials/participating-in-initial-meetings-with-regulators/learn-about-Pre-IND-meetings/](https://toolkit.ncats.nih.gov/module/prepare-for-clinical-trials/participating-in-initial-meetings-with-regulators/learn-about-Pre-IND-meetings/)
4. Administration, U. F. (2013, November). Preclinical Assessment of Investigational Cellular and Gene Therapy Products. Retrieved from [https://www.fda.gov/regulatory-information/search-fda-guidance-documents/preclinical-assessment-investigational-cellular-and-gene-therapy-products](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/preclinical-assessment-investigational-cellular-and-gene-therapy-products)
5. Administration, U. F. (2015, 10). IND Application Procedures: Clinical Hold. Retrieved from U.S. Food and Drug Administration: [https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-application-procedures-clinical-hold](https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-application-procedures-clinical-hold)
6. (n.d.). BGTC CMC Briefing Book & CQAs reviewed with FDA
7. Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Guidance for Industry. (2019, October 18). Retrieved from U.S Food & Drug Administration: [https://www.fda.gov/regulatory-information/search-fda-guidance-documents/formal-meetings-between-fda-and-sponsors-or-applicants-pdufa-products-guidance-industry](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/formal-meetings-between-fda-and-sponsors-or-applicants-pdufa-products-guidance-industry)
8. Good Laboratory Practice for Nonclinical Laboratory Studies. (2018, 03 26). Retrieved from U.S Food and Drug Administration: [https://www.fda.gov/about-fda/economic-impact-analyses-fda-regulations/good-laboratory-practice-nonclinical-laboratory-studies](https://www.fda.gov/about-fda/economic-impact-analyses-fda-regulations/good-laboratory-practice-nonclinical-laboratory-studies)
9. Michaela Sharpe, L. B. (October 2022). [Using analogue data to substantiate long-term durability of gene therapies: a narrative review - PubMed](https://pubmed.ncbi.nlm.nih.gov/35815392/)
10. OTP Pre-IND Meetings. (2022, 06 23). Retrieved from US Food & Drug Administration.
11. Rare Diseases: Natural History Studies for Drug Development. (2020, 04 15). Retrieved from U.S Food and Drug Administration: [https://www.fda.gov/regulatory-information/search-fda-guidance-documents/rare-diseases-natural-history-studies-drug-development](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/rare-diseases-natural-history-studies-drug-development)