# Safety Reporting Requirements for INDs and BA/BE Studies:  Guidance for Industry and Investigators – FDA Guidance

Source: https://www.keypedia.com/guidances/small-entity-compliance-guide/safety-reporting-requirements-for-inds-and-babe-studies-guidance-for-industry-and-investigators/f29cb314-c037-401d-9e00-b73921e58aee

> FDA guidance document: Safety Reporting Requirements for INDs and BA/BE Studies:  Guidance for Industry and Investigators. Issue date: October 19, 2026. Get complete insights and analysis.

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## Details

- Title: Safety Reporting Requirements for INDs and BA/BE Studies:  Guidance for Industry and Investigators
- Communication Type: Small Entity Compliance Guide
- Product Type: biologics
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2026-10-19
- Last Changed: 2026-10-19
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2010-D-0482">FDA-2010-D-0482</a>

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