IPEC EXCIPIENT UPDATED GMP GUIDE encourages drug excipient manufacturers to dedicate separate equipment for toxic and non- toxic products, Nutrilite Products Director of Quality Assurance Ofelia Barretto told the International Pharmaceutical Excipients Council annual meeting in Washington, D.C. Oct. 19. Use of equipment for multiple excipient products is not encouraged for toxic and non-toxic substances in the updated guide, Barretto noted.
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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.
