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EMA publishes updated reflection paper on RWD use in non-interventional studies

September 7, 2026

The European Medicines Agency has published a revised reflection paper setting out updated guidance on the use of real-world data

EMA publishes updated reflection paper on RWD use in non-interventional studies Read Post »

FDA issues draft guidance on AI/ML in drug development using real-world data

September 1, 2026

The FDA has published draft guidance addressing the use of artificial intelligence and machine learning tools in drug development contexts

FDA issues draft guidance on AI/ML in drug development using real-world data Read Post »

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