Advantages could be shorter review times and expanded labels, but there are concerns about no global regulator having access to full patient-level data.
FDA may want to conduct summary reviews of some NDA and BLA oncology supplements, but sponsors may not be able to take advantage of some of the benefits that should come with it.
A pilot project is under way in FDA’s oncology division to review supplements without using patient-level data and
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.’
New CBER Director Prasad will "unleash a massive" framework on vaccines, FDA Commissioner Marty Makary said 15 May, raising questions about the impact on products nearing approval.
BioMarin’s ultra-rare disease drug Brineura has breached cost-effectiveness thresholds for highly specialized treatments in England and looks set to be denied routine funding on the National Health Service.
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
