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Post-Market Safety Updates Replaced By “Periodic Benefit-Risk Evaluation Reports”

 
• By Martin Berman-Gorvine

Draft guidance from FDA would adopt the International Conference on Harmonization’s periodic benefit-risk evaluation reports, which will offer sponsors the opportunity to provide updates on benefit information along with safety signals to the regulatory authorities.

If FDA and the International Conference on Harmonization have their way, drug companies will submit efficacy updates and conduct reviews of the risk-benefit ratio of their approved products every time they submit periodic post-marketing reports.

The old ICH model called for “Periodic Safety Update Reports,” which FDA included in a proposed safety reporting rule nicknamed...

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