Growing Pipeline of Antisense Oligonucleotides Prompts Guidance
FDA’s newly proposed draft guidance will support IND filings of antisense oligonucleotides, a new class of drugs.
Following decades of research and study, a new class of drug, known as antisense oligonucleotides (ASO), are maturing as drug development efforts advance. In tandem with a growing ASO pipeline, FDA has recently issued a draft guidance, IND Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations Guidance for Sponsor-Investigators, for dealing with ASO investigational new drug filings.
Read this article in BioPharm International's Regulatory Sourcebook March 2021 eBook.
Article Details
BioPharm International
eBook: Regulatory Sourcebook, March 2021
March 2021
Pages: 6–10
Citation
When referring to this article, please cite it as F. Mirasol, “Growing Pipeline of Antisense Oligonucleotides Prompts Guidance," BioPharm International Regulatory Sourcebook eBook (March 2021).
Texas' MD Anderson Cancer Center Creates New Cell Therapy Institute
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