# Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report) - FDA Guidance Document

Source: 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

> FDA guidance document: Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report). Issue date: November 29, 2016. Get complete insights and analysis.

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## Details

- Title: Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report)
- 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: 2016-11-29
- Last Changed: 2024-12-19
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2013-D-0349">FDA-2013-D-0349</a>

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