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FDA's Opioid REMS Proposal Has Narrow Focus On Education
Faced with data gaps, inadequate metrics and the need to maintain access to therapies, FDA takes a narrow approach to addressing long-acting and extended-release opioid abuse and misuse in its proposed Risk Evaluation and Mitigation Strategy for the painkillers
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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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While Japanese government announces 8-15% price cuts for four drugs, including Leqembi, industry groups urge operational improvements to national cost effectiveness assessment scheme.
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Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.
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Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.