POST-1970s DRUG CGMPs begin taking shape with FDA’s first revision in more than a decade. Gone are references to asbestos and certain pre-automation work processes. In are some new provisions that conform to current practices and that harmonize with other nations’ regulations. FDA’s last major attempt to revise the cGMPs, an ill-fated 1996 proposal, is formally withdrawn, clearing the way to further conform U.S. cGMPs with emerging quality systems approaches.
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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.’
If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.
With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.
