Recently, the FDA has published a new Draft Guidance for Industry titled “Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medicinal Products”. The guidance document contains non-binding…
Today at Revio, we are reviewing and providing insights on Regulation (EU) 2021/2282 on Health Technology Assessment (HTAR), which entered into force on January 11, 2022, and will apply from…
We're excited to announce the publication of the EMA SME Office's 2023 annual report. This document outlines the Office's functions and their alignment with the needs of European small and…
Today, from Revio, we are thrilled to share that the U.S. Food and Drug Administration recently approved Lenmeldy (atidarsagene autotemcel), the first gene therapy indicated for the treatment of children…
On March, the European Medicines Agency (EMA) launched a new tool based in Artificial Intelligence (AI) for EU regulators. Scientific Explorer simplifies the daily work of the scientific staff involved…
Today, from Revio, we are thrilled to share that the U.S. Food and Drug Administration recently approved Amtagvi (lifileucel), the first cellular therapy indicated for the treatment of patients with…
New Projects on EMA’s Pilot for Academic and Non-profit ATMPsIn September 2022, the European Medicines Agency (EMA) launched a pilot program designed to support the transition of basic research into…
The concept paper on phage therapies for human health goal is to establish a scientific guideline for the pharmaceutical development and manufacture of bacteriophage medicinal products intended for the therapeutic…
Today, we at Revio are excited to share that the Food and Drug Administration (FDA) has announced the availability of a new draft guidance, titled "Potency Assurance for Cellular and…
The EMA’s PRIority MEdicines (PRIME) scheme and the FDA’s Breakthrough Therapy (BT) designation program are designed to expedite the development of innovative products that address unmet medical needs. However, the…
Revio is a Regulatory Affairs Consultancy – Created to support biopharmaceutical companies and public institutions, working with Advanced Therapy Medicinal Products (ATMPs)