INTERNEURON REDUX PHASE IV ADVISORY COMMITTEE REVIEW expected for Nov. 22 to address issues for post-marketing studies of the weight loss agent. Redux (dexfenfluramine) was approved on April 29 for weight loss management in the treatment of obesity. The original approval included requirements for two types of post-approval studies: "a clinical pharmacokinetic fast/fed study" and a "clinical neuropsychological function study." Wyeth-Ayerst has said that the drug is generating "an average rate of 65,000 new prescriptions each week."
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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 White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.
The reductions across medical product programs in the agency’s budget request include hundreds of positions funded by user fees, which may foreshadow its upcoming user fee restructuring strategy.
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
