Search Results for Advanced Therapies

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CBER Director Focuses on Flexibility to Advance Regenerative Medicines By Michael Mezher - Published 08 May 2017

Peter Marks, director of the US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) on Thursday said his office is equipped to support the development of cutting edge treatments, such as cell and gene therapies.

Categories: News, US, CBER, Biologics and biotechnology, Human cell and tissue, Regulatory strategy

Tags: Regenerative Medicine, Cell and Gene Therapy, Advanced Therapies, RMAT Designation

Advanced Therapy Medicinal Products: An Evolving Regulatory Landscape By Patricia Hurley, PhD, Sarah Jurmeister, PhD, Kathryn Parsley, PhD - Published 28 February 2017

This article was developed from a presentation at RAPS Regulatory Convergence in September 2016 in San Jose, California, US. It was the opening presentation in the "Global Developments in Cell and Gene Therapy" session and covered introductory Advanced Therapy Medicinal Product (ATMP) concepts from definitions to strategic considerations and challenges currently faced by developers in this field.

Categories: Features, Europe, US, EMA, FDA, Biologics and biotechnology, Human cell and tissue, Regulatory strategy

Tags: Advanced Therapies, ATMP

EC Report Analyzes Regulatory Frameworks for Advanced Therapies in US, Canada, Japan and Korea By Zachary Brennan - Published 06 July 2016

The European Commission report released Wednesday dissects the similarities in how gene-, cell- and tissue-based advanced therapies are regulated across the four different geographic regions, though ongoing research projects in such therapies are heavily concentrated in the US and Japan.

Categories: News, Asia, Canada, Europe, US, EC, EMA, FDA, Health Canada, MHLW, PMDA, Biologics and biotechnology, Clinical, Government affairs, Human cell and tissue

Tags: advanced therapies, gene therapies, reports on advanced therapies, gene therapy regulation

Advanced Therapies: Stakeholders Call for EMA Changes on Regulations, Manufacturing By Zachary Brennan - Published 03 June 2016

The European Medicines Agency (EMA) on Friday released a report outlining the concerns and regulatory changes described by developers, manufacturers and investors in advanced therapy medicinal products (ATMPs), which include gene therapies, tissue-engineered products and somatic cell therapies, at a meeting last week.

Categories: News, Europe, EC, Biologics and biotechnology, Blood, Clinical, Combination products, Crisis management, Government affairs, Human cell and tissue, Manufacturing, Quality, Regulatory intelligence, Regulatory strategy, Research and development

Tags: ATMPs, gene therapy manufacturing, cell therapy, advanced therapies

EMA Unveils 19 Advanced Therapy Product Classifications By Michael Mezher - Published 12 April 2016

The European Medicines Agency (EMA) on Tuesday released a host of classification decisions for advanced therapies being developed to treat various types of tissue damage, including burns, scars and non-healing wounds.

Categories: News, Europe, EMA, Human cell and tissue, Regulatory strategy

Tags: Advanced therapies, Tissue engineered produce, Somatic cell therapy

EMA Reflects on Advanced Therapy Classification By Michael Mezher - Published 08 June 2015

The European Medicines Agency (EMA) has released a new reflection paper discussing how products are classified as advanced therapy medicinal products (ATMPs).

Categories: News, Europe, EMA, Biologics and biotechnology, Human cell and tissue, Regulatory strategy, Submission and registration

Tags: Advanced therapy medicinal products, ATMP, Committee for Advanced Therapies, CAT

Following Negative Comments by Reviewer, EU Committee OK's Gene Therapy By Michael Mezher - Published 06 May 2015

Last month, German regulators postponed their review of UniQure's gene therapy Glybera after the European Medicines Agency (EMA) rapporteur assigned to the product claimed new data showed Glybera lacked efficacy and called for it to be reassessed.

Categories: Clinical, Postmarket surveillance, Regulatory strategy, Submission and registration

Tags: Committee for Advanced Therapies, CAT, G-BA, Federal Joint Committee, Glybera, UniQure, Gene therapy

First EU-Authorized Gene Therapy Hits Snag, Benefit Assessment Delayed in Germany as EMA Reviews New Report By Michael Mezher - Published 17 April 2015

Regulators at the German Federal Joint Commission (G-BA) have postponed their review of the gene therapy Glybera, Reuters reports. The decision was made after the European Medicines Agency (EMA) rapporteur assigned to Glybera found the product lacked efficacy and called for it to be reassessed.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Orphan products, Postmarket surveillance, Submission and registration

Tags: Glybera, Gene therapy, Committee on Advanced Therapies, CAT, Federal Joint Commission, G-BA

Paper: Small Companies Need Regulatory Assistance from EMA By Alexander Gaffney - Published 13 March 2012

Categories: Meetings, EMA

Tags: Advanced Therapies, Small Business, Scientific Advice, CAT, Latest News, regulation, regulatory