Woodruff, Wisc.-based Hillestad Pharmaceuticals is violating a 2000 consent decree by making unapproved drug claims for its dietary supplement products, FDA says in Oct. 1 "Talk Paper." The agency told the firm in a letter it may face a contempt proceeding if it does not cease claims made in promotional materials identified during a recent inspection. FDA "also directs the firm to pay liquidated damages in the amount of $23,000, which reflects sales of Opti-Cran, Hi-C Level, ginkgo biloba and St. John's wort that were made in violation of the court order." The consent decree was part of a settlement of an FDA/Department of Justice case against Hillestad for marketing unapproved new drugs...
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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.’
Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
Following EU approval of the first disease-modifying treatment for Alzheimer’s disease, and with a second expected soon, the European Medicines Agency plans to update its guidance to support the design of state-of-the-art clinical trials for the disease and enhance drug development.
50% tariffs on US imports from India, a range on others, an uncertain outcome of Section 232 investigations of pharma and talk of BRICS tariffs are making the forecasting environment for the pharma industry extremely difficult, the Pink Sheet finds in this infographic analysis.
