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Zdrowie i gospodarka · 17/06/2024

FDA Releases Final Guidance for Oligonucleotide Therapeutics Development

The FDA has released a final guidance document outlining clinical pharmacology considerations for the development of oligonucleotide therapeutics, addressing factors such as QT interval prolongation, immunogenicity risk assessment, and drug-drug interactions.

Source: Federal Register — Food and Drug AdministrationOpen original release →