RWE Regulatory News

MHRA published 16 June 2025 New Post-Market Surveillance (PMS) regulations have taken effect across Great Britain, requiring medical...

MaaT Press release 13 June 2025 MaaT will present updated data for Xervyteg® (MaaT013) in treating acute Graft-versus-Host Disease...

Published 21 May 2025 by  JASPREET TAKHAR ,  JULIA GILLERT  AND  ELINA ANGELOUDI The UK’s MHRA unveiled a major shift: a consultation on...

Published 9 June 2025 FDA website The FDA updated its comprehensive guidance on real-world evidence, emphasizing commitment to realizing...

Regulatory News:  21 March 2025 Joanne S. Eglovitch Regulators and a representative from the pharmaceutical industry discussed the...

By Randall Lutter 27 March 2025 New information technology gives the U.S. an opportunity to accelerate the development, review, and...

Reading time: 5mins (full article) On July 25, 2024, the US Food and Drug Administration (FDA) announced the release of a final version...