> ## 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.

# Antisense Oligonucleotide IND Clinical Recommendations
- URL: https://www.fdaweb.com/antisense-oligonucleotide-ind-clinical-recommendations/
- Published: 2021-12-08T12:00:00.000Z
- Updated: 2026-09-14T17:25:02.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150723

*Federal Register* notice: FDA has made available a draft guidance entitled *IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations*. The clinical recommendations specifically address the following clinical considerations: Ethical and human subject protection, diagnostic and genetic, dosing, administration, safety, and assessment of clinical response to treatment. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-12-08/pdf/2021-26453.pdf?ref=fdaweb.com).