Industry and Advocacy Groups Urge FDA to Allow More Real-World Data for Rare Disease Trials

Industry and Advocacy Groups Urge FDA to Allow More Real-World Data for Rare Disease Trials

Source: 
BioSpace
snippet: 

In January 2019, the U.S. Food and Drug Administration (FDA) updated a 2015 draft guidance on rare diseases. Although essentially agreeing with the changes, several organizations, both patient advocacy and industry groups, have called on the FDA to make additional changes.