EMA has recommended granting a conditional marketing authorisation for Carvykti (ciltacabtagene autoleucel) and it is now pending for European Commission decision.Medicines for human use are eligible for conditional marketing authorisation if…
In the development of an Advanced Therapy Medicinal Product (ATMP) involving the donation of human tissues or cells to be used as starting materials, the control of the materials, traceability,…
Today, for the Rare Disease Day, from Revio we would like to share the following information regarding the European Medicines Agency (EMA) orphan designation procedure for medicines for rare diseases.An…
To introduce the new year, from Revio we have made a compilation of the marketing authorizations granted during the year 2021 and up to February 2022 for Advanced Therapies by…
Today, from Revio, we would like to inform you that the European Medicines Agency has published the Revision 2 of the “Procedural advice on the provision of scientific recommendation on…
Today, from Revio, we would like to share with you a summary of the Food and Drug Administration (FDA) draft Guideline on Studying Multiple Versions of a Cellular or Gene…
Today, from Revio, we would like to share with some information on the regulatory framework regarding plasmids and Good Manufacturing Practices (GMPs) to help in the development of ATMPs that…
Today, from Revio, we would like to inform you that the European Medicines Agency recently published for public consultation a draft Guideline on core SmPC, Labelling and Package Leaflet for…
Today, from Revio, we would like to share with you a review on a piece of guidance from the Food and Drug Administration (FDA): Expedited Programs for Regenerative Medicine Therapies…
Today, from Revio, we would like to share with you a summary of the International Council for Harmonisation (ICH) guideline about nonclinical biodistribution considerations for gene therapy products. This draft…
Revio is a Regulatory Affairs Consultancy – Created to support biopharmaceutical companies and public institutions, working with Advanced Therapy Medicinal Products (ATMPs)