FDA PROPOSES SHARING CLINICAL DATA (Orthopedics This Week)
The FDA wants to share your clinical data with “non-FDA experts and other interested parties.”
The agency says data gained from patients participating in clinical trials should be “maximized” for the benefit of society. So the agency is proposing to share clinical and preclinical data derived from marketing applications after de-identifying and masking that data.
Safeguard Commercial Investments
However, the agency says it wants to do it in a way that would “both safeguard the privacy interests of patients enrolled in clinical trials, ...