In early April FDA launched a new performance management system that will assess more than 300 activities in its 100-plus offices, dubbed FDA-Track. Managers will report specific actions, which are posted every month for public viewing. For example, in January FDA received 52,101 adverse event reports, approved two REMS and granted approval to two first generics. Activities are tracked and analyzed through FDA-Track dashboards; CDER has dashboards for 10 offices, though data has not yet been compiled for several of those. FDA-Track is part of FDA's transparency initiative, its implementation of the Obama Administration's directive to agencies to be more transparent (1"The Pink Sheet" DAILY, April 7, 2010)
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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Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022.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.
