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Posts Tagged ‘draft guidance’

FDA Draft Guidance: Using EHR Data In Clinical Trials

We’ve talked a lot in this blog about the use of electronic health records (EHRs) in clinical trials. Recently, my colleague wrote about it on our healthcare blog, so, I thought I would share her post with my pharma and CRO friends. While our previous posts focused on the use of EHR for subject recruitment […]

Some Rare Disease Stats That Make Them Seem Rather Common

  We often hear the term “rare disease,” yet many of us still wonder exactly how “rare” is defined. In a recent blog post, Dr. Jonathan Goldsmith, the FDA’s Associate Director for Rare Diseases, shared some staggering statistics, as well as insights into how the FDA is making it easier to develop drugs for unusual […]