> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Consultants Submit Draft AAV Guidance to FDA
- URL: https://www.fdaweb.com/consultants-submit-draft-aav-guidance-to-fda/
- Published: 2022-05-17T12:00:00.000Z
- Updated: 2026-09-14T17:44:54.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5151830

Dark Horse Consulting Group has submitted to FDA a proposed draft guidance, *Testing of Adeno-Associated Viral (AAV) Vector-Based Human Gene Therapy Products for Empty Capsids During Product Manufacture*. The company [says](https://darkhorseconsultinggroup.com/dark-horse-submits-proposed-draft-guidance-to-fda-re-high-dose-aav-fte-capsid-ratio/?ref=fdaweb.com) the development of the [draft guidance](https://darkhorseconsultinggroup.com/proposed-draft-guidance-for-fda-consideration/?ref=fdaweb.com) was led by former CBER CMC reviewer **Donald Fink**, who has joined Dark Horse as a regulatory practice expert, and Dark Horse consultant **Christina Fuentes**.

Dark Horse says the proposal aims to offer a benchmarking goal in making a recommendation to establish a release criterion for empty AAV vector capsid impurity. “If FDA moves forward with a guidance informed by this recommendation,” the consulting firm says, “the result will be a reasonable, achievable impurity limit that will maximize efficiency while minimizing adverse side effects. It is important to note that the guidance retains the option for a data-driven demonstration of acceptable patient safety when the benchmark goal cannot be achieved.”