The Food and Drug Administration (FDA) announced a new proposal Monday for flexible drug approval pathway treatments addressing ultrarare diseases. The FDA unveiled draft guidance on a proposed ...

Global agencies have collaborated to create parallel regulatory approval solutions to help get drugs to patients more quickly. Experts who have used these schemes say that while these schemes have ...

Forbes contributors publish independent expert analyses and insights. Greg Licholai writes and teaches about innovation in healthcare. In a move that could dramatically reshape the landscape for rare ...

The FDA Modernization Act of 1997 established the Fast Track designation to expedite developing and reviewing new drugs designed to fill unmet medical needs and treat serious conditions. The FDA Fast ...