Labeling changes similar to those requested by U.S. FDA and the EC's CPMP are required for brandname and generic triazolam products, the Canadian Health Protection Branch announces Jan. 31. The recommended period for continuous use of triazolam in Canada has been shortened from 21 days to 14 days. The recommended starting dose will be lowered to .125 mg, with a maximum daily dose of .25 mg. The new warnings section will include adverse reactions such as memory disturbance, abnormal thinking and behavioral changes, confusion, anxiety and depression. The HPB also is considering whether labeling changes should be implemented for other benzodiazepines.
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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 group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.
Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.
The developers of the ChAdOx1 NipahB vaccine will be able to benefit from the early and enhanced support that the European Medicines Agency offers through its priority medicines scheme.
