Transparency at FDA
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 ClinicalTrials.gov
- 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 ClinicalTrials.gov 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
Blueprint for FDA transparency