As FDA rolls out its Good Review Management Principles - its attempt to improve FDA's timely review of drug applications through professional best practices - the agency is stressing the importance of sponsors submitting complete applications to facilitate this process
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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.’
The report gave examples of missed opportunities for innovation and patient access, as well as regulatory and operational problems that undermine the conduct of timely clinical trials in Europe.
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
Japan looks set to press ahead with a reimbursement price cut for Eisai's Alzheimer's drug Leqembi following a cost-effectiveness review, despite differences with the company over methodology.
