Posted by Michael Wonder on 09 Jan 2023
US FDA issues a CRL for the biologics license application for insulin-R
7 January 2023 - The US FDA has issued a complete response letter for the biologics license application for the insulin-R product filed by Biocon Biologics.
The letter cites additional data required in the submission and an expectation of a satisfactory implementation of a CAPA plan pertaining to the pre-approval inspection of the Company's Bangalore facilities in August 2022.
