New platforms for analyzing and visualizing large, complex datasets

  • Harness data to advance the safe and efficient development of new therapies
  • Tailor clinical care to individual patient characteristics and preferences
  • Communicate information supporting regulatory decision-making to engender greater public confidence

Advance transparency without reducing incentives to innovate

  • FDA’s Data Dashboard: publicly available datasets, data visualization tools 
  • openFDA
    • APIs and full sets of downloadable FDA data files for adverse events, drug product labeling, recall enforcement reports
    • supports open source user community, sharing of source code and techniques for use through GitHub, Twitter, and StackExchange

New Steps to filter information and harness it into more usable knowledge

  • Greater transparency and efficiency in NDA and BLA reviews
  • Track product development in clinical trials posted on the
  • Pilot (9 applications) to disclose key portions of Clinical Study Reports to decipher  key clinical evidence for approval decision
  • Add special identifier number to clinical trials registered through  and link to FDA communications (e.g. labeling, advisory committee materials)
  • Explore possibility – under existing statutory authority- to release Complete Response Letters (CRLs) information directly relevant to patients

Technology, no matter how powerful, is always just a tool

  • Commitment to transparent, responsible, and science-based use to save and improve lives

FDA Commissioner Statement

Blueprint for FDA transparency


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