FDA officials discuss the status of Safe Use Initiative activities and future projects at a public workshop in November. According to the agency's website, FDA will gather input and perspectives for directions toward the development of "collaborative, cross-sector safe medication use activities with healthcare stakeholders." FDA scheduled the meeting for Nov. 16, 8:30 a.m. to 4:45 p.m. EST, and Nov. 17, 8:30 a.m. to 12 p.m., in Silver Spring, Md. FDA launched the initiative in 2008 to reduce the likelihood of preventable injury and death caused by medical errors, unintentional exposure to drugs, misuse, abuse or attempts at self-harm (1"The Tan Sheet" May 10, 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.’
It appears that the European Medicines Agency is making progress on its re-examination of Eli Lilly’s Alzheimer’s disease drug Kisunla, following an initial rejection in March based on safety concerns.
Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.
Key expert panel go-ahead with a trial waiver put’s Eisai's Alzheimer's therapy on track for a debut in India where tailored pricing will be pivotal. Lilly’s Kisunla is also under regulatory review.
