After an almost two-year hiatus from strict adherence to the review timeframes set forth in the Prescription Drugs User Fee Act, Office of New Drugs Director John Jenkins has told the drug review staff that, once again, they should strive to meet the user fee deadlines.
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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.’
Final guidelines explaining how staff at Canada’s Patented Medicine Prices Review Board should go about identifying drugs that could be considered for an excessive price hearing will come into force soon.
Denmark is shaking up clinical trial timelines with a new process for reviewing applications for early-phase mono-national trials that is twice as fast as the standard timelines in the EU and the UK.
The legislation expected to be signed by President Trump is a mixed bag for pharmaceutical manufacturers depending on their product mix and manufacturing situation.
