Grassley Wants An Rx Safety Reorganization; Can FDA Keep Him At Bay Again? Congressional Avandia Investigation Reopens Door On Splitting CDER
Renewed congressional interest in a separate drug safety center at FDA is a likely off-shoot of a Senate Finance Committee report that questions GlaxoSmithKline's handling of cardiovascular safety issues surrounding Avandia
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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.’
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Pink Sheet reporter and editors discuss the most recent senior staff departures at the FDA and their impact on the agency, as well as Commissioner Martin Makary’s plans for a new approval pathway and a combined adverse event database as outlined in an interview with a podcast host.
The European Medicines Agency has recommended 16 drugs for EU-wide approval, including Vertex’s cystic fibrosis drug Alyftrek and five other orphans.
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.