FDA Pushes Back Against “Living” Benefit-Risk Assessment Management Plan
The Institute of Medicine urges the agency to create a publicly available document setting forth benefits and risks of drugs, with periodic updates, but FDA says it has no extra resources to handle such an effort.
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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.
Draft guidance from FDA would adopt the International Conference on Harmonization’s periodic benefit-risk evaluation reports, which will offer sponsors the opportunity to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.
FDA’s Endocrinologic and Metabolic Drugs Advisory Committee March 29 voted 17-6 that all obesity drugs should be vetted for cardiovascular risk, but some could rely on a meta-analysis rather than an outcomes trial.