# Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/electronic-submission-of-expedited-safety-reports-from-ind-exempt-babe-studies-guidance-for-industry/0ba6f618-8ff9-42f6-a368-058e7fd53088

> FDA guidance document: Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies Guidance for Industry. Issue date: April 01, 2024. Get complete insights and analysis.

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## Details

- Title: Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies 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: 2024-04-01
- Last Changed: 2024-04-01
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2022-D-1173">FDA-2022-D-1173</a>

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