# IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations: Draft Guidance for Industry - FDA Guidance Document

Source: https://www.keypedia.com/guidances/guidance-document/ind-submissions-for-individualized-antisense-oligonucleotide-drug-products-for-severely-debilitating-or-life-threatening-diseases-clinical-recommendations-draft-guidance-for-industry/2fbda0fb-0b43-42de-8bce-881ee5336b6e

> FDA guidance document: IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations: Draft Guidance for Industry. Issue date: December 08, 2021. Get complete insights and analysis.

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## Details

- Title: IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations: Draft Guidance for Industry
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2021-12-08
- Comment Close Date: 2022-02-07
- Last Changed: 2022-10-21
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2021-D-1140">FDA-2021-D-1140</a>

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