Evaluating Nonclinical Safety of Therapeutics Based on Oligonucleotides
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While comments can be submitted at any time regarding guidance (refer to 21 CFR 10.115(g)(5)), it is advisable to send your comments on the draft guidance before the final version is worked on by the FDA to ensure they are taken into consideration. You may submit comments online or in written form before the closing date.
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Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
Ensure all written comments are labeled with the docket number of this document: FDA-2024-D-4624
- Docket Number:
- FDA-2024-D-4624
- Issued by:
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Guidance Issuing Office
Center for Drug Evaluation and Research
The Food and Drug Administration (FDA or Agency) has released a draft guidance for industry titled “Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics.” This draft outlines recommendations aimed at the nonclinical safety evaluation of oligonucleotide-based therapeutics (ONTs) to facilitate their clinical development and market entry. ONTs present distinct challenges and opportunities in nonclinical safety evaluation, which differ significantly from those for small molecule drugs or therapeutic proteins.