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

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

Detailed guidance document from FDA and regulatory agencies.

Document Details

Document Type

Guidance Document

Issue Date

November 29, 2016

Last Updated

December 19, 2024

Office

Center for Drug Evaluation and Research

Document ID

39cb6b72-e49f-4e02-ba0b-172f4a5701a2

Related Documents

Providing Submissions in Electronic Format — Postmarketing Safety Reports

Guidance DocumentApril 27, 2022Center for Drug Evaluation and Research

View Details →

Pre-Launch Activities Importation Requests (PLAIR): Guidance for Industry

Guidance DocumentMarch 1, 2022Center for Drug Evaluation and Research

View Details →

Tropical Disease Priority Review Vouchers

Guidance DocumentOctober 6, 2016Center for Drug Evaluation and Research

View Details →

Quick Actions

Transform Regulatory Data into Actionable Intelligence

Join leading pharmaceutical and medical device companies who trust GKS for their regulatory compliance needs.

Try KeyPedia Today

Explore our real use cases and discover our features in depth.

Subscribe to our newsletter

Get the latest updates and insights delivered to your inbox