Gilead and Novartis Seek to Expand What FDA Considers as Real-World Data and Real-World Evidence

Gilead and Novartis Seek to Expand What FDA Considers as Real-World Data and Real-World Evidence

Source: 
RAPS.org
snippet: 

Just over two months ago, the US Food and Drug Administration (FDA) released draft guidance explaining to drugmakers what constitutes real-world data (RWD) and real-world evidence (RWE) and how to submit such data to the agency.