The European Commission is inviting stakeholder feedback on recommendations to help implement several key aspects of the new EU Clinical Trials Regulation, including how to apply a risk proportionate approach for the design and conduct of trials, and how to present a summary of clinical trial results to laypersons1.
The European Commission is inviting stakeholder feedback on recommendations to help implement several key aspects of the new EU Clinical Trials Regulation, including how to apply a risk proportionate approach for the design and conduct of trials, and how to present a summary of clinical trial results to laypersons1.
It is also seeking feedback on a revised definition of an investigational medicinal product (IMP) and on recommendations regarding ethical...
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 guidance from the National Pharmaceutical Regulatory Agency responds to the medicines shortages crisis that Malaysia experienced a few years ago.
Vertex and Biogen are working with the Dutch government to ensure access for eligible patients.
Aurobindo is confident its planned Lannett acquisition will meet US FTC standards after an attempt to acquire Sandoz assets was nixed in 2020. The deal also could widen Aurobindo’s US manufacturing presence.
