Benefit-Risk Assessment Framework Moves Toward Global Harmonization
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.
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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.
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.
Sponsors and regulators continue to develop methodologies with a range of complexity for presenting, communicating and discussing a drug’s risks and benefits.