Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics; Draft Guidance for Industry; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics." FDA is publishing this draft guidance which, when finalized, will provide recommendations on approaches for the nonclinical safety evaluation of oligonucleotide-based therapeutics (ONTs) to support clinical development and marketing of these products. ONTs present unique challenges and opportunities in the nonclinical evaluation of safety that differ in many regards from those appropriate for small molecule drugs or therapeutic proteins.
Abstract as published in the Federal Register.
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