Drug recalls surged last year as global outsourcing took toll. Inappropriate ingredients from China contributed to record 32 Class I recalls, including heparin adulterant and erectile dysfunction API. Meanwhile, U.S. facilities help drive total recalls to 426 - the highest level in seven years. Economic forces and corporate culture played contributing roles. Sage, Hydrox, Sandoz, KV, Actavis, other recall cases explored.
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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.’
Brazil plans to clarify its medicine pricing framework, for example by outlining the procedures for setting medicine prices and bring it up to date with recent developments in the sector.
England’s health technology assessment institute explains how its sandbox environment is helping to test new evaluation methods for drugs or indications with which it does not have experience, such as metabolic dysfunction-associated steatohepatitis.
The European Medicines Agency, like its counterpart in the US, is increasingly focusing on the use of alternatives to animal testing.
