Capitol Hill In Brief
Omnibus stalls: Congress March 6 extends a continuing resolution to fund most federal agencies through March 11 at fiscal 2008 levels while the House and Senate continue deliberating an omnibus package covering the rest of fiscal 2009. The previous continuing resolution expired March 6 (1"The Tan Sheet" Oct. 6, 2008, p. 9). The House Feb. 25 passed a $410 billion dollar omnibus package, H.R. 1105, including $2.6 billion for FDA, but the bill has stalled in the Senate (2"The Tan Sheet" March 2, 2009, p. 9). Votes are expected March 9 on Republican amendments and March 10 on the Senate's version of the omnibus covering federal agencies other than the departments of Defense and Homeland Security, which were funded in separate legislation Congress enacted in 2008
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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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While the pharma industry appears to be exempt from US tariffs imposed by President Trump, a member of the UK House of Lords says the details are unknown and warned that uncertainty “leads to less investment” in business as a whole.
The EU Clinical Trials Information System has achieved primary registry designation in the International Clinical Trials Registry Platform in a move that is expected to reduce regulatory burden for companies and help them lower compliance costs by aligning with publication requirements in medical journals.
The UK government has listened to industry concerns about high clawback rates under the voluntary scheme and will review it in June in a bid to resolve the issue and “move on to bigger and more important things,” health secretary Wes Streeting says.