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FDA To Adopt Cost-Effectiveness Role? Congress May Revisit Issue, Crawford Says
Medicare reform will link FDA more closely with CMS, which could necessitate FDA becoming more economically aware of approval decisions, Acting Commissioner Crawford says. FDAer envisions a relationship with CMS that is akin to a merger.
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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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The FDA's Oncologic Drugs Advisory Committee will consider whether appropriate dosages of belantamab mafodotin have been identified for two second-line, multiple myeloma indications. Ocular toxicities and large number of dose modifications in trials raised FDA concerns about benefit-risk.
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The official separation of those impacted by the reduction-in-force and some others who are leaving the agency are not yet reflected in CDER employee gains and losses data.
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A new plan to tackle medicine shortages proposes to develop a set of incentives for companies to manufacture essential medicines in Spain.