House Food Safety Price Tag Exceeds Budget Request – Hamburg
FDA Commissioner Peggy Hamburg says House draft legislation gives the agency authorities it needs for food safety reform, but does not include sufficient funding for the costs of increased enforcement
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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.’
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While drug companies say they support the European Medicines Agency’s expanded OPEN framework for the collaborative assessment of marketing applications with non-EU authorities, they are reluctant to participate in the initiative for a number of reasons.
The Council of the EU wants to adopt its negotiating position on the reform of the general pharmaceutical legislation “sooner, rather than later,” but divergence between member states could push negotiations back another year, a European Commission policy officer said today.
In an interview with the Pink Sheet, Fonadazione Telethon’s Stefano Benvenuti discusses how companies developing and marketing rare disease treatments can overcome the challenges presented by EU-joint clinical assessment evidence requirements.