# Investigational New Drug Applications (INDs) - Determining Whether Human Research Studies Can Be Conducted Without an IND:  Guidance for Clinical Investigators, Sponsors, and IRBs - FDA Guidance Document

Source: https://www.keypedia.com/guidances/guidance-document/investigational-new-drug-applications-inds-determining-whether-human-research-studies-can-be-conducted-without-an-ind-guidance-for-clinical-investigators-sponsors-and-irbs/83e34c5d-552a-445c-81e3-be44082f30a8

> FDA guidance document: Investigational New Drug Applications (INDs) - Determining Whether Human Research Studies Can Be Conducted Without an IND:  Guidance for Clinical Investigators, Sponsors, and IRBs. Issue date: September 10, 2013. Get complete insights and analysis.

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## Details

- Title: Investigational New Drug Applications (INDs) - Determining Whether Human Research Studies Can Be Conducted Without an IND:  Guidance for Clinical Investigators, Sponsors, and IRBs
- Communication Type: Guidance Document
- Product Type: food
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2013-09-10
- Last Changed: 2024-10-01
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2010-D-0503">FDA-2010-D-0503</a>

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