All Priority review voucher articles
-
JournalAccelerated regulatory pathways: Vaccines for tropical diseases
Reproduced from an online seminar presentation, made in collaboration with TOPRA and hVIVO, given on 21 June 2022 by Bruno Speder from hVIVO.
-
CPD SupplementThe Olaratumab experience
As highlighted within this CPD article, a conditional marketing authorisation (CMA) can be revoked in Europe. However only one occurrence has occurred since 2006 (in April 2019). Lartruvo (olaratumab), a humanised antibody, was granted a CMA via accelerated assessment on 9 November 2016 for adult patients with a locally advanced, ...
-
FocusTime is running out for the rare pediatric disease designation and priority review voucher programs
Since 2012, the rare paediatric disease priority review voucher (RPD PRV) program in the US, provides incentives to promote research in leftover orphan paediatric disease...
-
CPD SupplementExpedited drug development regulatory pathways in the EU and the US
This continuing professional development (CPD) supplement focuses on the regulatory framework available to drug developers for expediting their products’ development and review processes in the EU and US. These mechanisms are relevant for products which address an unmet medical need in the treatment of a serious and/or life-threatening condition.