In this overview of the user fee legislation making its way through Congress, Catalyst’s Ms. Myers comments on the new FDA review model for NMEs and novel biologics. “Drug developers feel there really is value in getting FDA’s perspective early to avoid surprises in an application review,” she says in the article. She is also quoted on her predictions for passage of the bill, noting that “most members of Congress want to go home with a satisfying health-care bill under their belt.”

FDA’s $6.4 Billion Plan for Quick Reviews Moves to Senate