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.
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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.
Fees set to be introduced to cover the cost of the European Medicines Agency’s part in improving drug safety could impose a huge burden on the EU pharmaceutical industry and lead to the closure of smaller firms, the industry says.
Sponsors and regulators continue to develop methodologies with a range of complexity for presenting, communicating and discussing a drug’s risks and benefits.