# Providing Submissions in Electronic Format — Postmarketing Safety Reports - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/providing-submissions-in-electronic-format-postmarketing-safety-reports/4ad827be-5b2f-4a35-a05b-6c58d6dbc5ff

> FDA guidance document: Providing Submissions in Electronic Format — Postmarketing Safety Reports. Issue date: April 27, 2022. Get complete insights and analysis.

---

## Details

- Title: Providing Submissions in Electronic Format — Postmarketing Safety Reports
- 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: 2022-04-27
- Last Changed: 2024-12-19
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2001-D-0067">FDA-2001-D-0067</a>

## Related Documents

- [Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report)](https://www.globalkeysolutions.net/guidances/guidance-document/providing-postmarket-periodic-safety-reports-in-the-ich-e2cr2-format-periodic-benefit-risk-evaluation-report/39cb6b72-e49f-4e02-ba0b-172f4a5701a2)
- [Providing Regulatory Submissions in Electronic Format: IND Safety Reports Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/providing-regulatory-submissions-in-electronic-format-ind-safety-reports-guidance-for-industry/d8a7e884-2739-4461-b12b-7feef9321c17)
- [Tropical Disease Priority Review Vouchers](https://www.globalkeysolutions.net/guidances/guidance-document/tropical-disease-priority-review-vouchers/5a29b7d1-5c71-4f17-b7d0-4c04b9df5ed1)