FDA's warning May 12 to consumers not to swallow Benadryl Extra Strength Itch Stopping Gel is another blow to manufacturer Johnson & Johnson's reputation following multiple high-profile recalls by the firm's subsidiary McNeil Consumer Healthcare (1"The Tan Sheet" May 10, 2010). The agency warned the public not to consume the gel when it discovered 121 adverse event reports linked to cases of mistaken ingestion of the gel - seven of which were serious - between 2001 and 2009. FDA said consumers confused the topical product with Benadryl oral liquid products, which have similar consistency and packaging. The agency did not ask J&J to stop using the umbrella name for the product as it recently asked Novartis to rebrand a Maalox line extension that was not an antacid (2"The Tan Sheet" Feb. 22, 2010). However, J&J has added "For Skin Use Only" to the product labeling and launched consumer studies to identify other causes of confusion
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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.
