A comparison of post-marketing measures imposed by regulatory agencies to confirm the tissue-agnostic approach

HIGHLIGHTS

• who: Jorn Mulder from the Oncode Institute, Amsterdam, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, Dx-Rx Institute, Denmark have published the research: A Comparison of Post-marketing Measures Imposed by Regulatory Agencies to Confirm the Tissue-Agnostic Approach, in the Journal: (JOURNAL) of May/23,/2017
• what: These included the Multi-Discipline Reviews from the FDA, the European Public Assessment Reports (EPARs) from the EMA, and the Review Reports from the PMDA. This study was conducted to compare decision-making aspects of tissue-agnostic approvals between regulatory agencies.
• how: The following . . .
  

   

  

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