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# IND Guide for Antisense Oligonucleotide Products
- URL: https://www.fdaweb.com/ind-guide-for-antisense-oligonucleotide-products/
- Published: 2021-12-08T12:00:00.000Z
- Updated: 2026-09-14T17:25:01.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150724

*Federal Register* notice: FDA has made available a draft guidance entitled *IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations.* The document provides FDA’s recommendations on the chemistry, manufacturing, and controls information needed to support an IND for an individualized antisense oligonucleotide for a severe disease caused by a unique genetic variant affecting a small number of individuals. It also explains FDA’s recommendations around GMP compliance. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-12-08/pdf/2021-26454.pdf?ref=fdaweb.com).