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RWR CONTEXT A tangible example of how real world evidence (RWE) can be used to support label extensions for existing drugs. Note the FDA’s emphasis on: “This approval reflects how a well-designed, non-interventional study relying on fit-for-purpose real-world data [...]
RWR CONTEXT At first glance, the General Practice Data for Planning and Research (GPDPR) seems innocuous. The UK’s NHS is making GP patient data available for research purposes. What isn’t made clear, is that this is an ‘opt out’ [...]
RWR CONTEXT This major revision to the BfArM website is likely to have impacted any (all) links to their website created before 1 July 2021. Recommend you check and update hyperlinks to the new BfArM website. 1 [...]
RWR CONTEXT The EMA references this standard in the context of non-interventional post-authorisation safety studies (PASS) as: “Relevant scientific guidance should be considered [= Recommendation, not a legal mandate] by marketing authorisation holders and investigators for the development of [...]
RWR CONTEXT This is a complete refresh of the guidance for applying for permits for clinical trials of medical devices and also covers the requirements for post approval studies of medical devices. Note that Guide no. 9761 of 10 [...]
RWR CONTEXT We’re revisiting this change in case you missed it. The CN RIPH system has been replaced with the CPP Information System (SI RIPH 2G), which means you will need to replace any mentions of (and hyperlinks to) [...]
