IoM’s Drug Safety Cmte. Will Meet In June; Panel Includes Ex-FDAer Ellenberg
The Institute of Medicine's Drug Safety Committee will convene June 8 to begin discussing its review of FDA's post-marketing oversight system
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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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Joshi joins the parent company of Citeline, home of the Pink Sheet, to focus on AI, business harmonization and long-term growth.
Data is “the new oil,” but its use will challenge regulators, while inertia is the biggest disrupter of all for European regulators, according to European Medicines Agency chiefs past and present.
Pharma firms are being encouraged to respond to a European Commission consultation on planned updates to its good manufacturing practice standards which reflect the “rapid advancement” of modern technologies, like AI and digital systems, in drug manufacturing.