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# Guide on Oligonucleotide Drug Development
- URL: https://www.fdaweb.com/guide-on-oligonucleotide-drug-development/
- Published: 2022-06-27T12:00:00.000Z
- Updated: 2026-09-14T17:50:06.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5152178

*Federal Register* notice: FDA is making available a draft guidance entitled “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics.” The document describes FDA’s recommendations for developing such products, including characterizing the potential for QT interval prolongation, performing immunogenicity risk assessments, characterizing the impact of hepatic and renal impairment, and assessing the potential for drug-drug interactions. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-06-27/pdf/2022-13606.pdf?ref=fdaweb.com).