Cole Werble
This is a pivotal moment for drug safety regulation. Congress is poised to take up legislation to overhaul the Food & Drug Administration’s post-marketing safety system
Refining Data Mining: Taking Control of a Powerful New Tool
FDA is about to get more money and new technology to upgrade its drug safety systems. One new technique likely to emerge in a big way is "data mining"-automated safety signal detection. The question is: who will mind the data miners?
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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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Silicon Valley investor Jim O’Neill’s Senate confirmation hearings showcased the unique background of someone with government and tech experience and avoided discussions of his past statements about lowering the bar for regulatory approval.
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The FDA continues to wait for a decision on whether its priority guidances will be published as HHS asks the public for potential regulation cuts to fulfill President Trump’s executive order.
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A new ordinance for addressing drug shortages in Austria requires drug companies distributing any of the hundreds of products listed in an accompanying annex to maintain adequate stock in the country to meet patient demand for four months.