FDA And PBRERs (PSURs)

By Bart Cobert

In April 2013 FDA issued a brief guidance entitled Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report). This document summarizes FDA’s position on accepting the new format EU/EMA PSURs known as PBRERs (pronounced “pee-bers”).

A brief review of the new and old PSUR situation. The PSURs (Periodic Safety Update Report) have been around for many years. They are standardized and accepted by most health authorities (including FDA, Health Canada, the EU). A PSUR covers one entity (all indications, dose forms, routes of administration and regimens). They include an analysis and evaluation of new or changing safety data received during the period covered by the PSUR which includes:

• Analysis of ADRs & lack of efficacy cases,
• An interval data review. Minimal cumulative overviews
• Safety data from studies
• Other relevant safety information
• Pregnancy experiences
• Increased frequency where meaningful
• Follow up of any Risk Management Plans in place
• Timing of submission was rigid (in the EU: every 6 months for 2 years, yearly for 2 years then every 3 years forever).