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# Guide on Nonclinical Safety for Oligonucleotides
- URL: https://www.fdaweb.com/guide-on-nonclinical-safety-for-oligonucleotides/
- Published: 2024-11-14T12:00:00.000Z
- Updated: 2026-09-14T14:47:06.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5158183

*Federal Register* notice: FDA is making available a draft guidance entitled “Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics.” The document provides recommendations on approaches for the nonclinical safety evaluation of oligonucleotide-based therapeutics (ONTs) to support clinical development and their marketing. The agency notes that ONTs “present unique challenges and opportunities in the nonclinical evaluation of safety that differ in many regards from those appropriate for small molecule drugs or therapeutic proteins.” To view the notice, click [here](https://public-inspection.federalregister.gov/2024-26682.pdf?ref=fdaweb.com).