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Understanding the evidence used in drug product withdrawals

European Pharmaceutical Review

Our research showed that in Europe between 1999 and 2016, 35 products were withdrawn. This may come as a surprise because RCTs are seen as the gold standard of drug development, and they certainly have their place. Article (Samantha Lane): How can evidence-based medicine (EBM) methodology support drug withdrawals?

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Deep 6 AI: the smart software breathing new life into clinical trials

pharmaphorum

Patient recruitment and retention in clinical trials have long been significant challenges for drug developers. Four years before the pandemic, in 2016, Wout set up Deep 6 AI. However, Deep 6 AI has developed cutting?edge changing treatment. edge technology that pulls insights from this chaotic data in minutes.

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Guidance on Standardizing Terminology and Collection: Another Step in FDA’s Path to Increasing Diversity and Inclusion in Clinical Trials

FDA Law Blog: Biosimilars

The Draft Guidance emphasizes that study team should not answer the questions based on observation or even on existing medical records. When finalized, the Draft Guidance will take the place of the 2016 guidance Collection of Race and Ethnicity Data in Clinical Trials. The comment period ends on April 29, 2024.