FDA is considering developing a guidance on the use of epidemiological data in order to facilitate post-marketing surveillance. The document would advise industry on the analysis of large safety databases. The expansion of funding for post-market drug surveillance activities is under discussion as part of the fourth renewal of the Prescription Drug User Fee Act next year (1"The Pink Sheet" Nov. 21, 2005, p. 3)...
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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 new FTC chair addressed concerns that staffing cuts will undermine the commission’s commitment to pharmacy benefit manager oversight.
Joint procurement, if used by member states to respond to potential pricing and access challenges caused by a US most favored nations pricing policy, would cause more uncertainty for pharmaceutical companies, warn industry representatives.
Sponsors can expect faster evaluation processes for key medicines and greater support in mitigating medicines supply shortages this year as part of the European Medicines Agency’s digital transformation overhaul.
