Benefit-Risk Assessment Framework Moves Toward Global Harmonization
Executive Summary
PhRMA shifts further development of its structured benefit-risk assessment framework to the European organization CIRS, which has relationships with regulators in Europe, the U.S. and elsewhere that can drive the framework’s adoption for the drug approval process.
You may also be interested in...
Benefit-Risk Assessment Framework Pushes Into Post-Approval Arena
An industry/regulator working group will flesh out the processes involved in the eight-step framework and identify data that can be used at each step, in both the pre-market and post-market stage.
FDA’s Structured Benefit-Risk Assessment Framework To Come Online In FY 2014
Drug reviews will include a benefit-risk summary assessment that states the rationale for regulatory action on a drug or biologic application and explains how differences of opinion among reviewers were resolved.
International Group Finds Harmony In Benefit-Risk Assessment Framework
Sponsors and regulators continue to develop methodologies with a range of complexity for presenting, communicating and discussing a drug’s risks and benefits.