FDA Protocol Reviews Would Include Outside Consultants Under PDUFA III
The PDUFA III agreement between FDA and industry includes a provision that would allow sponsors to request the participation of outside consultants in protocol design meetings
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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.’