The Center for Food Safety & Applied Nutrition's Adverse Event Monitoring System will be supported by approximately $2.5 mil. in FY 2000 funding as well as by an outside contractor in the process of being hired, center Director Joseph Levitt testified at a May 27 House Government Reform Committee hearing on CFSAN's monitoring of dietary supplements.
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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 European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.
Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.
Pfizer told the Pink Sheet it would work with the health technology assessment institute, NICE, with the hope of making Hympavzi available to patients with hemophilia A via the National Health Service.
