Proposed reg could face another long delay as it undergoes reexamination by FDA/HHS under Bush Administration following withdrawal from OMB Feb. 1 (1"The Tan Sheet" Feb. 5, In Brief). Reg may have to wait for new FDA commissioner and likely would be an issue at confirmation hearings, industry sources speculate. Last acting commissioner served approximately 20 months
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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.’
A newly launched UK government inquiry is seeking to learn how viable it would be to bring back domestic control over the entire drug manufacturing pipeline.
Learn how advances in vaccine adjuvants are shaping the future of global health and driving more effective immunization strategies
Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.
