Growing Pipeline of Antisense Oligonucleotides Prompts Guidance

BioPharm International, BioPharm International-03-15-2021, Volume 2021 eBook, Issue 1
Pages: 6–10

FDA’s newly proposed draft guidance will support IND filings of antisense oligonucleotides, a new class of drugs.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 In tandem with a growing ASO pipeline, FDA has recently issued a draft guidance, IND Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations Guidance for Sponsor-Investigators,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).