House Appropriators Tip-Toe Into Biologics Transition Controversy
Executive Summary
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."
You may also be interested in...
Heritable Genetic Modification Debate May Ignite Again As Technology Advances
CBER Director Peter Marks said the US may have to consider whether to maintain its ban on the practice of creating embryos to include heritable genetic modifications if other countries allow the practice.
Senate Wants Priority Review For 'Deemed' Biologics Not Approved By Deadline
Appropriations report directs the US FDA to offer the faster assessment and allow reliance on prior data submitted for applications caught in the transition from drug to biologic regulation.
Mylan/Biocon’s Insulin Glargine Has Narrow Window For Approval In US
Thirty-month stay resulting from Sanofi’s patent lawsuit expires on 18 March 2020, two days before Mylan’s application must receive final approval to avoid getting caught in the transition of insulins from drug to biologic regulation. Pre-approval inspection of Biocon’s manufacturing facility resulted in 12 ‘largely procedural’ observations, company says.