By Rep. Rosa DeLauro (D-Conn.)
Since the days of President Lincoln, the National Academies have been a tremendous resource for those of us in government...
Regulatory Science: A Legislator's Perspective
Agriculture Appropriations Subcommittee Chair Rosa DeLauro is a critical figure in FDA’s quest to secure expanded resources to support regulatory science. The good news: she believes in the cause. The bad news: she has a lot of other changes she would like to see at FDA.
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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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A draft international guideline on using adaptive trial designs says sponsors should provide a clear rationale for using such designs to address the potential ‘tension’ between the confirmatory nature of late-stage trials and the flexibility introduced by mid-trial adaptations.
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Newly introduced rules for streamlining drug registration in Vietnam are said to present both opportunities and challenges for stakeholders.
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At Medicines for Europe’s legal and annual conferences in Brussels last week, multiple key issues competed for attention, giving the generics and biosimilars industry plenty to think about at a critical time for EU pharma reform.