FDA's Transparency Initiative Enters The "What Is The Right Thing To Do" Phase: An Interview With Principal Deputy Commissioner Sharfstein
In June, FDA launched an internal Transparency Task Force to evaluate how to make the agency's decision-making process more accessible to the public. The agency held two public meetings and solicited comments from the public; the docket closed Nov. 6. FDA Principal Deputy Commissioner Joshua Sharfstein, who chairs the task force, spoke to "The Pink Sheet" about its initial findings
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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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Data is “the new oil,” but its use will challenge regulators, while inertia is the biggest disrupter of all for European regulators, according to European Medicines Agency chiefs past and present.
Pharma firms are being encouraged to respond to a European Commission consultation on planned updates to its good manufacturing practice standards which reflect the “rapid advancement” of modern technologies, like AI and digital systems, in drug manufacturing.
China has announced a raft of new measures to encourage innovative drug development across the product life cycle, including using insurance data to differentiate new therapies and applying commercial insurance to selected novel products.