Anatomy Of The Avandia Decision: FDA’s Woodcock Splits The Difference Between OND, OSE Views
In deciding to keep GlaxoSmithKline PLC’s Avandia on the market, while also heavily restricting its use, FDA Center for Drug Evaluation and Research Director Janet Woodcock split the difference between opposing recommendations from the Office of New Drugs and Office of Surveillance and Epidemiology.
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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 UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.
Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.
The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.