Federal investigators seized more than $1 million in strength-training supplements from LG Sciences in Brighton, Mich., on April 2 after the firm failed to respond to FDA's warnings about the use of adulterated ingredients in the products, the agency says. FDA asked the U.S. Marshalls Service and the U.S. Attorney's Office in the Eastern District of Michigan to seize the Methyl 1-D, Methyl 1-D XL and Formadrol Extreme XL products from LG Sciences, according to an April 4 release. The firm's products, which were cited in a March 2006 warning letter from the agency, allegedly contain one or more unapproved food additives or new dietary ingredients that lack adequate evidence to show they are safe, FDA says. LG Sciences legal representative, Ronald Berry, said the products' ingredients are "perfectly" compliant with the Dietary Supplement Health and Education Act. Berry added the products' seizure "makes no determination of liability or the correction of [FDA's] allegations"....
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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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In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.
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.
