Kansas becomes the fifth state to take up the Consumer Healthcare Products Association's offer to monitor methamphetamine precursor purchases at no cost to the state. Missouri, Illinois, Kentucky and Louisiana have already said they will implement the industry-funded National Precursor Log Exchange to help enforce purchase limits for pseudoephedrine-containing OTCs. CHPA announced the Kansas Board of Pharmacy's decision March 22. While Mississippi recently became the second state to make all PSE drugs available Rx only, CHPA hopes other states will elect to use the tracking system (1"The Tan Sheet" Feb. 8, 2010)
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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.’
The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US
Ongoing questions about user fees exerting too much influence over the FDA could spawn a shift in the PDUFA structure when talks begin later this year.
Vincenza Trivigno will take over as executive director from Raimund Bruhin, who is retiring after over seven years in the post.
