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FDA MedGuide Distribution Guidance May Mean Little Change For Manufacturers
FDA is demonstrating its intent to use discretion in enforcement with a draft guidance aimed at clarifying when Medication Guides must be distributed. However, as a practical matter, pharmaceutical manufacturers may still have to maintain their existing distribution systems for the guides.
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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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A newly launched UK government inquiry is seeking to learn how viable it would be to bring back domestic control over the entire drug manufacturing pipeline.
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Learn how advances in vaccine adjuvants are shaping the future of global health and driving more effective immunization strategies
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Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.