|Articles|March 15, 2021

BioPharm International

  • BioPharm International-03-15-2021
  • Volume 2021 eBook
  • Issue 1

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FDA’s newly proposed draft guidance will support IND filings of antisense oligonucleotides, a new class of drugs.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 In tandem with a growing ASO pipeline, FDA has recently issued a draft guidance, IND Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations Guidance for Sponsor-Investigators,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

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