FDA's final guidance on non-inferiority studies in antibiotic drug development is little changed from the 2007 draft version, but provides further clarity for sponsors working under an SPA.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
The Danish Medicines Agency is requesting that data from bioequivalence studies to be submitted in the CDISC format in addition to the current eCTD format. It believes the move will make it easier for the agency claims to access and analyze data and will reduce the burden for applicants.
Sam Roberts, chief executive of the health technology assessment institute, NICE, will step down from her role at the end of the year. The agency is now on the lookout for a new leader, who will be the fourth in its history.
The ups – and some downs – of the US FDA’s prescription, biosimilar, and generic user fees for FY 2026 are tabulated by the Pink Sheet.
