FDA’s newly proposed draft guidance will support IND filings of antisense oligonucleotides, a new class of drugs.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 In tandem with a growing ASO pipeline, FDA has recently issued a draft guidance, IND Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations Guidance for Sponsor-Investigators,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.
BioPharm International
eBook: Regulatory Sourcebook, March 2021
March 2021
Pages: 6–10
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).
Psilera, Hesperos Agree to Accelerate Organ-on-a-Chip Treatment for Frontotemporal Dementia
June 9th 2025The partnership leverages the Hesperos organ-on-a-chip platform in the preclinical development of Psilera’s lead compound targeting the progressive neurological disorder for which treatment options are few.