The Oligonucleotide Safety Working Group (OSWG) was established at the inaugural Food and Drug Administration (FDA) and Drug
Information Association (DIA) Oligonucleotide-Based Therapeutics Conference in 2007, with a mission to facilitate the exchange of information between industry, academia, and regulatory authorities on the emerging new class of oligonucleotide-based therapeutics. The OSWG has created subcommittees on various aspects of oligonucleotide safety assessment, including genotoxicity, off-target effects, reproductive toxicology and carcinogenicity, exaggerated pharmacology, safety pharmacology, and immunomodulatory effects. The subcommittees have published multiple whitepapers intended to provide consensus scientific recommendations, in hopes of facilitating successful approval of oligonucleotide-based therapeutics.
