# Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies: Draft Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/sponsor-responsibilities-safety-reporting-requirements-and-safety-assessment-for-ind-and-bioavailabilitybioequivalence-studies-draft-guidance-for-industry/3ddf69d5-0ade-4f23-bd0b-b3c057455a7c

> FDA guidance document: Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies: Draft Guidance for Industry. Issue date: June 25, 2021. Get complete insights and analysis.

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## Details

- Title: Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies: Draft Guidance for Industry
- Communication Type: Guidance Document
- 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: 2021-06-25
- Comment Close Date: 2021-09-24
- Last Changed: 2022-02-01
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2020-D-2099">FDA-2020-D-2099</a>

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