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Zdrowie i gospodarka · 27/06/2022

FDA Releases Draft Guidance on Clinical Pharmacology for Oligonucleotide Therapeutics

The FDA has released a draft guidance outlining its recommendations for clinical pharmacology considerations during the development of oligonucleotide therapeutics, aiming to help industry conduct studies on QT interval prolongation, immunogenicity, and drug interactions.

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