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.
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A Pink Sheet infographic shows how insulins account for the largest category of transition products, with 27 NDAs that will be "deemed" BLAs in six months; agency is working on a policy to address the transition of authorized generic insulins to regulation under the PHS Act, Office of Therapeutic Biologics And Biosimilars acting policy director Eva Temkin says.
Now most, if not all, assessment divisions within the Office of New Drugs have dealt with issues surrounding small trials and rare diseases, defying common belief that experience was spread unequally.
After second complete response letter, Mylan and Biocon have just over six months to resolve manufacturing issues and obtain full approval or face having to resubmit the insulin as a biologics license application.