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- Experts call for modernizing rare disease evidence models using FDA plausible mechanism frameworkA recent paper in The Journal of Clinical Investigation argues that the evidentiary approach for rare diseases needs updating. The authors suggest applying the FDA’s plausible mechanism framework,…
- EMA launches consultation on draft framework to speed adoption of data standardsEMA has opened a public consultation on a draft framework aimed at accelerating the implementation of data standards across the pharmaceutical sector. The agency says the new framework is intended…