What real-world data will regulators consider in Europe?

A 2024 Data Quality Framework (DQF) from the European Medicines Agency (EMA) aims to provide some guidance for drug manufacturers. Here is a summary of that document. Factors to be considered when evaluating RWD Key factors to be considered in the EMA’s DQF include: Reliability: Are the data correct?Extensiveness: Are the data enoughCoherence: Are the…

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Who Will Pay If ACA Tax Credits Lapse?

About 22 million Americans would face sharply higher healthcare costs if enhanced ACA tax credits expire at the end of the year. Experts warn that the impact would extend beyond just families relying on ACA courage — also straining hospitals, increasing uncompensated care and potentially costing the economy hundreds of thousands of jobs. The post…

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