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

Source: https://www.globalkeysolutions.net/guidances/small-entity-compliance-guide/safety-reporting-requirements-for-inds-and-babe-studies-guidance-for-industry-and-investigators/5e899308-bd5d-4267-9d7e-71f434a2b8db

> FDA guidance document: Safety Reporting Requirements for INDs and BA/BE Studies:  Guidance for Industry and Investigators. Issue date: December 20, 2012. 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: 2012-12-20
- Last Changed: 2020-04-24
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2010-D-0482">FDA-2010-D-0482</a>

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