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# Students Suggest Ways to Improve FDA Draft Antisense Oligonucleotide Guidance
- URL: https://www.fdaweb.com/students-suggest-ways-to-improve-fda-draft-antisense-oligonucleotide-guidance/
- Published: 2021-03-18T12:00:00.000Z
- Updated: 2026-09-14T16:51:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148916

Three students in the Duke Science Regulation Lab, an interdisciplinary course offered through the Duke University law and graduate schools, recommend several steps FDA could take to improve a draft guidance, *Investigational New Drug Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations*. The comment [letter](https://downloads.regulations.gov/FDA-2020-D-2199-0008/attachment%5F1.pdf?ref=fdaweb.com) says that while the draft “provides an excellent framework for sponsors to develop individualized antisense oligonucleotides, the agency should further improve it by: 

- clarifying what constitutes “convincing proof of data” for pre-IND meeting requests and IND application submissions;
- helping sponsors with preclinical and clinical trial design; and
- · flagging and communicating unique bioethical considerations for individualized antisense oligonucleotide therapies for patients with rare diseases, including the importance of family involvement in the medical decision-making process, unique privacy concerns, and the high cost of treatment after the investigational stage.