...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.’
The UK drug regulator acknowledges that technology will “move on” and, as such, has designed its decentralized manufacturing regulation to be as “enduring” as possible. Experts from the MHRA explain what products are covered by the new framework and how it has been future-proofed.
The European Medicines Agency expects the International Council for Harmonization’s new guideline will help address the critical lack of data on the use of medicinal products in pregnant and breastfeeding populations.
A differentiated profit-sharing model to accelerate the use of AI in drug development using clinical and patient data is being proposed in South Korea, but the idea faces multiple practical challenges
