Business · 29/11/2016
FDA Releases Guidance on Postmarketing Safety Reports in ICH E2C(R2) Format
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 →