JETPHARMA AG MICRONIZATION CROSS-CONTAMINATION caused by a "lack of distinction between bulk drugs and finished pharmaceuticals" micronized at the company's Balerno, Switzerland plant, FDA notes in a Nov. 10 waning letter. The agency uncovered good manufacturing practice deviations in the micronizing processes for bulk israpidine (Sandoz' DynaCirc) and other bulk drugs, including "steroids, non-penicillin antibiotics, nonsteroidal anti-inflammatory drugs and anti-diabetics using common processing areas and equipment," during an inspection of Jetpharma from June 30 to July 1, the warning letter notes.
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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 reductions across medical product programs in the agency’s budget request include hundreds of positions funded by user fees, which may foreshadow its upcoming user fee restructuring strategy.
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
A European Medicines Agency official provided an overview and update of the support the EMA offers developers of innovative products and discussed, among other things, its Innovation Task Force, Quality Innovation Group and a scientific advice pilot for clinical trials.
