FDA Web site
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.’
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Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance.
A blanket pricing agreement CSL has formed with German health insurers for the gene therapy, Hemgenix, makes the cost of treatment budget-neutral compared to traditional treatment.
Japan's trade ministry is providing new support to build domestic capacity for new modalities including cell and gene therapies, as part of wider efforts to support the national bioventure ecosystem.