FDA Expects STD Claims Enforcement To Deter Future Violations
FDA will consider prosecuting executives of firms making unapproved sexually transmitted disease treatment claims for OTC drugs and nutritional products, the targets of its latest enforcement sweep.
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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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The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
The lack of a formal analysis of efficacy in castration-resistant prostate cancer patients without HRR mutations doomed Pfizer’s Talzenna at the US FDA's Oncologic Drugs Advisory Committee, as FDA oncology chief Richard Pazdur says chance cannot be ruled out.