# Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/investigational-new-drug-applications-prepared-and-submitted-by-sponsor-investigators/9c10b828-60b1-4f2f-acda-7011cf2ad95d

> FDA guidance document: Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators. Issue date: May 15, 2015. Get complete insights and analysis.

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## Details

- Title: Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators
- 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: 2015-05-15
- Last Changed: 2020-05-14
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2015-D-1484">FDA-2015-D-1484</a>

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