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EMA Guidance: A Guide to the HMA-EMA Real-World Evidence Catalogues
As the role of real-world data (RWD) and real-world evidence (RWE) grows in drug development, regulatory decision-making, and...

Sharan Murugan
Jun 18, 20253 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...

Sharan Murugan
Apr 16, 20242 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...

Sharan Murugan
Sep 8, 20221 min read
