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# Guide on Oligonucleotide Clin/Pharm Considerations
- URL: https://www.fdaweb.com/guide-on-oligonucleotide-clin-pharm-considerations/
- Published: 2024-06-17T12:00:00.000Z
- Updated: 2026-09-14T14:33:29.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5157193

*Federal Register* notice: FDA is making available a final guidance entitled “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics,” which provides recommendations for developing oligonucleotide therapeutics. It addresses FDA’s current thinking about clinical pharmacology considerations and recommendations for oligonucleotide therapeutic development programs, including characterizing the potential for QT interval prolongation, performing immunogenicity risk assessment, 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-2024-06-17/pdf/2024-13271.pdf?ref=fdaweb.com).