Recently, the European Medicines Agency (EMA) has published its Human Medicines Highlights 2022 report, a report including figures on the authorisation of medicines and a selection of new treatments that…
The Office of Tissues and Advanced Therapies (OTAT) from the FDA’s Center for Biologics Evaluation and Research (CBER) hosted last week a town hall answering stakeholder questions related to the…
On 31 January 2023, the use of the Clinical Trials Information System (CTIS) will become mandatory for new clinical trial applications (CTA). It will serve as the single-entry point for…
Recently, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has issued positive opinions recommending the grating of a market authorization of two different Advanced Therapy Medicinal Products (ATMPs).…
ContentAbout the Quality of the Game Support TeamMultiplier structureFrom Sketch to Screen Unlike most online casino slots, Chicken Road Game doesn’t feature classic bonus mechanics like Free Spins or Wild…
New EMA Reflection paper on the evaluation of New Active Substance status of biological substances Recently, the EMA has published a new reflection paper reflecting the current experience on New…
FDA has recently issued a new final Guidance for Industry on Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial. The purpose of this…
EMA has recommended granting a marketing authorisation in the European Union for Upstaza (eladocagene exuparvovec). This is a gene therapy for the treatment of adult and paediatric patients with severe…
Today, from Revio, we would like to share with you the latest updates on the scientific recommendations that European Medicines Agency’s Committee for Advanced Therapies (CAT) delivers on whether a…
Today, from Revio, we would like to share with you a summary on a recent draft guidance document published by the US Food and Drug Administration (FDA): “Considerations for the…
Revio is a Regulatory Affairs Consultancy – Created to support biopharmaceutical companies and public institutions, working with Advanced Therapy Medicinal Products (ATMPs)