May 24, 2023
FDA
The new article addresses the aspects related to special factors to be considered when developing a monitoring plan, the way centralized monitoring should be implemented, and also emphasizes the importance of maintaining blinding to mitigate risks associated with...
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Dec 27, 2020
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority, has published an update regarding the ongoing process of improvement of the existing regulatory framework in the sphere of post-market monitoring and surveillance. In particular, the TGA...
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Jul 18, 2019
North America
RBM is essential in clinical trials, where sponsors monitor clinical investigations and determine any problems or risks involved with their studies that could impact participants or the general public. The FDA wants to improve this monitoring system to make it quicker...
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