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Time Waits for No Lab, Ranbaxy Learns
Time waits for no lab learn Ranbaxy and new owner Daiichi Sankyo as stock sinks after FDA sanctions firm for holding stability testing samples in refrigerators until its overworked lab could get around to testing them. Lab was backdating same-day testing of 30-, 60- and 90-day samples, FDA said as it slapped Ranbaxy with application integrity letter.
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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.’
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Canada’s drug regulator is using amended drug laws to increase the use of regulatory reliance pathways to improve efficiency and support international alignment, while the UK’s MHRA has held talks with Australia’s TGA on topics including the role of AI in regulatory frameworks.
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Shortlists of potential winners in all categories of the Citeline Japan Awards 2025 have now been released. Join us at the event in Tokyo on October 21, it’s not too late to book your table!
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The former CDC director and recently departed chief medical officer tell senators that Kennedy plans to target the childhood vaccine schedule despite a lack of scientific data to support his agenda.