FDA's cGMP regulation revisions reflect the agency's increasing focus on compliance for OTC manufacturers, according to Scott Bass of the Washington, D.C. law firm Sidley, Austin, Brown & Wood
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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 proportion of China-originated drugs granted expedited reviews in China doubled in the first half of this year, Pharmaprojects data show, surpassing those receiving similar treatment in the US and likely driven by multiple factors.
The FDA recommended removal of a voluntary hold on shipments of the gene therapy to younger patients after finding that the death of an 8-year-old boy in Brazil was unrelated to Elevidys. Discussions on safety of DMD treatment for non-ambulatory patients is ongoing.
While the 15% rate is a substantial blow for pharmaceutical firms, the US-EU deal provides a framework for trade agreements with other countries that could see the industry avoiding higher tariffs elsewhere.
