Allows consumers to electronically report Web sites that may be illegally selling drugs, devices, dietary supplements, foods or cosmetics. The consumer reporting form, which is automatically submitted to the Office of Regulatory Affairs' enforcement division, applies to "problem" sites that do not involve life-threatening or serious reactions. ORA will investigate the sites and prosecute any that are unlawful. FDA is working with FTC and the Justice Department to investigate questionable sites and Internet sales practices
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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.’
If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.
With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.
