The European Medicines Agency has proposed a more systematic way of extrapolating data from adult studies to support decision-making on the evaluation and approval of medicines for use in children.
The European Medicines Agency has proposed a more systematic way of extrapolating data from adult studies to support decision-making on the evaluation and approval of medicines for use in children.
In a draft reflection paper, the EMA says the aim of its proposals is to minimize the number of children...
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.’
Six deaths early in treatment inspired a new safety requirement for Biogen/Eisai’s Leqembi to promote early identification of patients affected by the well-known risk of amyloid-related imaging abnormalities with edema (ARIA-E).
The CBER director rejected Pfizer’s assertions that pediatric dosing gaps, supply constraints and comparative mRNA content justify keeping the vaccine under emergency use authorization for younger children.
The agency is creating two new AI councils to facilitate its role in responsible AI adoption and regulation.
