FDA Issues New Guidance: Nonclinical Safety Assessment Of Oligonucleotide-Based Therapeutics FDA (CDER) issued a draft guidance in November 2024, Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics (ONT), to support clinical development and marketing of these products. As is customary, industry has 60 days to assess it and reply with feedback for consideration. This guidance should be considered with the also recently issued guidance by EMA2 on the development and manufacturing of oligonucleotide-based therapies to see that the two, although covering slightly different topics, are extremely complementary. In this article, Peter Calcott, Ph.D., FRSC, president and CEO of calcott consulting offers an overview of the guidance principles. https://lnkd.in/dd4k757X
