The European Union has awarded a grant of 25.5€ million for the Accelerating Research and Innovation for Advanced Therapies (ARDAT) project.
Following the news and updates from the MHRA and to ensure that all the involved parties can prepare for the new scenario, the Agency has published a guidance on QPPV including PSMF from 1 January 2021.
With the end of the year around the corner, the transition period after Brexit is about to come to an end. From 1 January 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) will be the United Kingdom’s standalone medicines and medical devices regulator.
Vernos forzados a realizar teletrabajo ha hecho que nos demos cuenta de muchas cosas. Cosas que podemos mejorar y formas de trabajo que deberíamos cambiar. Pero ¿qué es eso que tenemos que cambiar? ¿Hay alguna forma de mejorar?
We are very pleased to announce the launch of the AsphaTrainings Program. We think it is essential to keep our Regulatory Affairs community updated and trained during this time. As a response to the postponement of most educational events in the field of Regulatory Affairs due to COVID-19, our aim is to offer high quality RA Content.
On January 17th, 2018, the European Commission granted Ciclopirox (L2.7.D7) the Orphan Drug Designation (ODD) and few months later, on 17th April 2018, the Food and Drug Administration (FDA) also granted ODD for the product. This is the first time that the agencies issue a positive opinion for this rare disease. Therefore, Ciclopirox represents the only drug with ODD for this genetic condition. Asphalion and Atlas have been working together in this challenging process for ODD application.