Generic Biologics: 505(b)(2) Route Still Open, But Scientific Issues Unresolved
FDA is declining to rule out the possibility that the Sec. 505(b)(2) process could be used to allow expedited approval of follow-on biologic projects
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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.’