New FDA Draft Guideline for Oligonucleotide Therapeutics

In June 2022 the FDA published a draft version of a new guideline about “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics”. The guideline provides recommendations to assist the industry in the development of oligonucleotide therapeutics. This poses new challenges for oligonucleotide therapeutics developers and manufacturers. Maria Fauth, Department Manager Oligonucleotides at Kymos, explains (...)

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