FDA Guidance

FDA Guidance News To manage tracking of submissions that include real-world data (RWD) and real-world evidence (RWE), the FDA has released a final guidance asking

CEO: George DeMuth, Statistical Expert George began his career as a statistician at Burroughs Welcome and went on to start a successful statistical consulting and

Understanding FDA Study Data Standards The U.S. Food and Drug Administration (FDA) has study data standards that provide a consistent general framework for organizing study

COVID-19: Factors Affecting Conduct of Clinical Trials As clinical programs face challenges following the pandemic, companies have continued to adapt to the impact. Hurdles have

FDA releases Artificial Intelligence Action Plan Overview As the healthcare industry continues to transform through innovative technologies in the Artificial Intelligence space, the U.S. Food