US FDA Expediting ANDA Postapproval Manufacturing Changes Due To COVID-19 Impacts
Generic drugs program has approved almost 300 manufacturing changes to help shore up the supply chain, with some prior approval supplements being downgraded to ‘changes being effected’ supplements, FDA officials said at GDUFA III kick-off meeting.
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GDUFA III: Excipients Group Seeks Seat At Negotiating Table, But US FDA Skeptical
IPEC-Americas requests an improved communications channel with the FDA and formal inclusion in talks to reauthorize the generic drug user fee program; agency says industry negotiators generally represent product manufacturers and API suppliers that are subject to user fees.
Teva’s Rx For GDUFA III: Treat Complex Generics More Like NDAs
New drug review elements that could benefit complex generics include a two-month filing review period before the user fee clock is triggered, more interaction between the agency and a sponsor during the review, and an opportunity for a company to have in-depth discussions with the FDA after receipt of a complete response letter, Teva’s Scott Tomsky says at kick-off meeting for next iteration of the generic drug user fee agreement.
How US FDA And Industry Are Looking To Navigate New Supply Chain Data Reporting Requirements
FDA Commissioner Hahn says industry needs to work with the agency to establish a link to more detailed supply chain information.