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.’
Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says the EU pharma reform is “not an improvement on the status quo” in its current form.
Oncology trial sponsors in the UK are being invited to participate in a pilot that aims to tackle duplication and variation in pharmacy reviews, which are an important part of setting up clinical trials in the National Health Service.
The new Advisory Committee on Immunization Practices voted for new recommendations on the decades-old thimerosal safety issue and lays intellectual groundwork to revisit other past controversies and decisions.
