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US FDA Wants More Examples Of Real-World Data Use

 
• By Derrick Gingery

CDER Director Woodcock says for regulatory purposes, using real-world data likely will remain a case-by-case decision.

Yellow road sign with a blue sky and white clouds: clinical trial

The US FDA does not appear ready to add indications to drug labels solely based on real-world evidence, even if the correlations to clinical trial data are strong, but still wants the experiments to be done.

Ultimately, the more attempts at making the leap that are seen, the easier it will be for FDA to write...

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