The biggest changes that came out of the FDA Amendments Act, the last round of Prescription Drug User Fee Act reauthorization, were FDA's augmented drug safety authorities, most specifically the Risk Evaluation and Mitigation Strategy tool. Going into the next round of PDUFA negotiations, a major focus will be on improving the implementation of the REMS program
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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.’
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.
Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.
