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GUIDANCE DOCUMENT

Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics Guidance for Industry June 2024

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2022-D-0235
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance provides recommendations to assist industry in the development of oligonucleotide therapeutics under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and 21 CFR parts 312 and 314. Specifically, this guidance represents the FDA’s recommendations for certain evaluations during development of oligonucleotide therapeutics, including: (1) characterizing the potential for QTc interval prolongation, (2) performing immunogenicity risk assessment, (3) characterizing the impact of hepatic and renal impairment, and (4) assessing the potential for drug-drug interactions. This guidance provides recommendations on when to conduct these assessments and what types of assessments are suitable to address the topics listed above.

Additional Guidance Resources:

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All written comments should be identified with this document's docket number: FDA-2022-D-0235.

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