Regulatory Blog

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Apr 162 min read

EMA Guidance: Real-World Evidence for supporting Regulatory Decision-Making

On 12 April 2024 the European Medicines Agency released "Guidance on real-world evidence provided by EMA: support for regulatory...

Sep 8, 20221 min read

USFDA Guidance: Submitting Documents Using Real-World Data & RW Evidence for Drug & Biologics

Earlier today (08-September-2022) USFDA's Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research...