FDA is in the midst of a hiring frenzy to rebuild a severely understaffed agency. The good news is that the center for drugs is about halfway through the process, with the Office of New Drugs receiving the bulk of new hires. It's not equal across review divisions-some are receiving more new people than others.
By Kate Rawson
It’s amazing what slashing a little red tape can do.
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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.’
The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”
The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.
Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.
