By Michael McCaughan
The meeting was entitled "Post-Market Drug Safety – The World After FDAAA," but the Institute of Medicine could easily have...
FDA Drug Safety Update: Key Takeaways From IoM Workshop
It has been three years since an Institute of Medicine report on FDA's drug safety system, and two years since the landmark FDA Amendments Act that followed. As those anniversaries approached, IoM convened a workshop for an update on the changes at FDA since FDAAA. Here's what we heard.
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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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The Health and Human Services Secretary made incorrect statements about the status of key industry priorities at a recent House hearing, which actually may be a good thing for drug sponsors.
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HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.
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Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.