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House Appropriators Tip-Toe Into Biologics Transition Controversy

 
• By Derrick Gingery

US FDA instructed to use the "Program" when assessing insulin applications with review goals before the 2020 transition date, but appropriations report does not explicitly urge elimination of the application "dead zone."

Capitol House
The US FDA's FY 2020 appropriations bill now moves to the full House of Representatives for consideration. • Source: Shutterstock

US House appropriators addressed the so-called regulatory "dead zone" for insulin products about to switch from regulation as drugs to regulation as biologics, although not as forcefully as recently-proposed Senate legislation.

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