...give evidence to FDA’s current concern with data integrity. The agency’s findings are spurring further investigations and public warnings to companies to pay attention to their operations. A planned field office reorganization and cutbacks could impact FDA enforcement activity and challenge the boundaries of risk management. [A dicussion by a field compliance official of FDA’s current concerns with data integrity and steps to avoid problems is included. The drug GMP warning letters issued in FY 2006, nearly as low in number as in FY 2005, are listed. The listing is organized according to the type of facility involved, and includes the recipient’s name, letter date, plant location and a description of the problem areas cited.]
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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.
