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# Guide on Antisense Oligonucleotide Drug Development
- URL: https://www.fdaweb.com/guide-on-antisense-oligonucleotide-drug-development/
- Published: 2021-04-26T12:00:00.000Z
- Updated: 2026-09-14T16:56:27.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5149184

*Federal Register* notice: FDA is making available a draft guidance entitled *Nonclinical Testing of Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases*. The document focuses on such products being developed to treat rapidly progressing, severely debilitating or life-threatening disease attributable to a unique genetic variant or variants that may be amenable to RNA-directed treatment. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-08675.pdf?ref=fdaweb.com).