Business · 29/11/2016Updated: 10/17/2026 · 1 min read

FDA Releases Guidance on Postmarketing Safety Reports in ICH E2C(R2) Format

Summary

The FDA has announced the availability of a guidance document outlining the conditions and procedures for submitting postmarketing safety reports in the ICH E2C(R2) format, which can replace traditional reports for certain pharmaceutical companies.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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