Summary of Advanced Therapies approved in 2021 by EMA and FDA
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…
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…
Today, from Revio, we would like to share with you a review of the Industry Guidance on manufacturing of cellular and gene therapy products (CGT) authorised by the Food and…
Today, from Revio, we would like to share with you a summary of the Reflection paper on clinical aspects related to tissue engineered products (EMA/CAT/573420/2009) adopted 19 September 2014.Tissue engineered…
In November 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a revision on the EMA’s Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically…