Global Regulators Join Hands To Boost RWE Use In Decision-Making
Existing challenges to using real-world evidence such as heterogeneous data sources around the world and the various governance models for data sharing and access will need to be addressed.
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Collaboration Makes The (Real) World Go Round: Global Efforts Strive To Anchor RWE With Real-World Data Standards And Practices
Can the decentralized global healthcare ecosystem to turn real-world evidence from a buzzword to a useful approach to fit-for-purpose evidence generation?
EMA Recommends Revoking EU Approval For Novartis’s Sickle Cell Disease Drug
The results of a Phase III study did not confirm the benefits previously seen with Adakveo, the European Medicines Agency said.
EMA Backs EU Approval For Ztalmy & Pylclari; Roches Withdraws EU Filing For AMD Implant
Two new products, one for epilepsy and the other for prostate cancer, were recommended for EU approval during the latest monthly meeting of the European Medicines Agency’s human medicines committee, the CHMP.