Business · 07/08/2019
FDA Establishes Public Docket for Oligonucleotide Therapeutics Evaluation
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 →