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Read more about the article New FDA Guidance on Safety Testing of Human Allogeneic Cells

New FDA Guidance on Safety Testing of Human Allogeneic Cells

  • Post published:June 4, 2024

Recently, the FDA has published a new Draft Guidance for Industry titled “Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medicinal Products”.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…

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Read more about the article Insights on the New EU Health Technology Assessment Regulation (HTAR)

Insights on the New EU Health Technology Assessment Regulation (HTAR)

  • Post published:May 20, 2024

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…

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Read more about the article EMA’s SME Office 2023 Annual Report

EMA’s SME Office 2023 Annual Report

  • Post published:May 8, 2024

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…

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Read more about the article New Gene Therapy for Children with Metachromatic Leukodystrophy Approved by FDA

New Gene Therapy for Children with Metachromatic Leukodystrophy Approved by FDA

  • Post published:April 23, 2024

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…

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Read more about the article Scientific Explorer: EMA’s AI Tool to Improve Scientific Advice

Scientific Explorer: EMA’s AI Tool to Improve Scientific Advice

  • Post published:April 9, 2024

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…

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Read more about the article New Cellular Therapy for Unresectable or Metastatic Melanoma Approved by FDA

New Cellular Therapy for Unresectable or Metastatic Melanoma Approved by FDA

  • Post published:March 19, 2024

 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…

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Read more about the article New Projects on EMA’s Pilot for Academic and Non-profit ATMPs

New Projects on EMA’s Pilot for Academic and Non-profit ATMPs

  • Post published:March 5, 2024

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…

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Read more about the article EMA’s concept paper on phage therapies for human health

EMA’s concept paper on phage therapies for human health

  • Post published:February 20, 2024

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…

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Read more about the article FDA Releases New Guidance on Potency for Cell and Gene Therapy Product

FDA Releases New Guidance on Potency for Cell and Gene Therapy Product

  • Post published:February 6, 2024

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…

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Read more about the article EMA–FDA Joint Q&A on Quality and GMP Aspects of PRIME/Breakthrough Therapy Applications 22-01-2024

EMA–FDA Joint Q&A on Quality and GMP Aspects of PRIME/Breakthrough Therapy Applications 22-01-2024

  • Post published:January 22, 2024

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…

Continue ReadingEMA–FDA Joint Q&A on Quality and GMP Aspects of PRIME/Breakthrough Therapy Applications 22-01-2024
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Revio is a Regulatory Affairs Consultancy – Created to support biopharmaceutical companies and public institutions, working with Advanced Therapy Medicinal Products (ATMPs)

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