Business · 07/08/2019Updated: 10/17/2026 · 1 min read

FDA Establishes Public Docket for Oligonucleotide Therapeutics Evaluation

Summary

The FDA is seeking public comments on the clinical pharmacology of oligonucleotide therapeutics, focusing on hepatic and renal impairment, drug-drug interactions, and immunogenicity, to inform study design and regulatory assessment.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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