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Filtering on: "topics human cell and tissue"

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FDA Unveils New Regenerative Medicine Framework By Zachary Brennan - Published 16 November 2017

The US Food and Drug Administration (FDA) on Thursday launched a new policy framework for regenerative medicine, building off a previous framework from 2005, as part of efforts to bring new cell, stem cell and tissue products to patients as efficiently as possible while managing the proliferation of unscrupulous actors hawking unproven therapies.

Categories: News, US, FDA, Biologics and biotechnology, Human cell and tissue, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: regenerative medicine, RMAT, FDA guidance

Asia Regulatory Roundup: Australia’s TGA to Tighten Regulation of Autologous Cell Products, Ban Ads (31 October 2017) By Nick Paul Taylor - Published 31 October 2017

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CFDA, TGA, Biologics and biotechnology, Human cell and tissue, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, autologous cell products, surgical mesh

EMA, European Commission Look to Foster Development of Advanced Therapies By Zachary Brennan - Published 20 October 2017

The European Medicines Agency (EMA) and European Commission on Friday published a joint action plan to further the development of new cell and gene therapies, as well as other advanced therapy medicinal products (ATMPs).

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Government affairs, Human cell and tissue

Tags: ATMPs, gene therapy EU

New California Law Requires Posted Notices of Non-FDA Approved Stem Cell Products By Zachary Brennan - Published 04 October 2017

California Gov. Jerry Brown this week signed into law a bill that requires health providers to post notices in their offices when they are administering stem cell treatments that have not been approved by the US Food and Drug Administration (FDA).

Categories: News, US, FDA, Biologics and biotechnology, Crisis management, Human cell and tissue

Tags: stem cell products, stem cell treatments, unapproved stem cells

Preparing for Market: Reimbursement Strategies for Cell and Gene Therapies Published 08 September 2017

In this interview with Regulatory Focus, Ted Slocomb and Michael Werner, two leaders from the Alliance for Regenerative Medicine (ARM), provide insight into future challenges and opportunities for ensuring market access and value-based reimbursement for gene and cell therapies.

Categories: Features, US, FDA, Biologics and biotechnology, Human cell and tissue, Reimbursement

Tags: Regenerative Medicine, ARM, Michael Werner, Ted Slocomb

FDA Finalizes Guidance on Deviation Reporting for HCT/Ps By Zachary Brennan - Published 06 September 2017

The US Food and Drug Administration (FDA) on Wednesday finalized guidance to help manufacturers of non-reproductive human cells, tissues and cellular and tissue-based products (HCT/Ps) understand the agency’s recommendations and relevant examples for complying with the requirements to investigate and report HCT/P deviations.

Categories: News, US, FDA, Biologics and biotechnology, Human cell and tissue

Tags: HCT/Ps, human tissues, FDA final guidance

'Historic Action': FDA Approves First CAR-T Therapy By Zachary Brennan - Published 30 August 2017

The US Food and Drug Administration (FDA) on Wednesday approved the first gene therapy, Novartis' Kymriah (tisagenlecleucel) for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL).

Categories: News, US, FDA, Business and Leadership, Government affairs, Human cell and tissue, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: Kymriah, CAR-T, gene therapy, FDA approved gene therapies

FDA to Unveil New Regulatory Framework for Stem Cell Therapies By Zachary Brennan - Published 28 August 2017

The US Food and Drug Administration's (FDA) Commissioner Scott Gottlieb said Monday the agency this fall will advance a new framework to regulate stem cell therapies.

Categories: News, US, FDA, Biologics and biotechnology, Crisis management, Government affairs, Human cell and tissue, Regulatory intelligence, Regulatory strategy

Tags: stem cell therapy, FDA on regenerative medicine, DTC stem cell clinics

FDA: US Clinical Research Using Three-Parent Baby Technique is Illegal By Zachary Brennan - Published 07 August 2017

The US Food and Drug Administration (FDA) said Friday that it is illegal to perform research in the US on a new type of technology that showed promise last year in helping a woman who had multiple miscarriages because of a genetic disorder to give birth to a baby boy in Mexico without that disorder.

Categories: News, US, FDA, Government affairs, Human cell and tissue, Regulatory intelligence, Regulatory strategy

Tags: mitochondrial replacement therapy, MRT, three parent baby technique, Leigh's syndrome,

FDA Panel Votes Unanimously in Favor of First CAR-T Cancer Therapy By Zachary Brennan - Published 12 July 2017

The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee on Wednesday voted unanimously, 10 to 0, in favor of the benefit-risk profile for the first of a new kind of cancer therapy, known as a Chimeric Antigen Receptor T-cell (CAR-T) therapy.

Categories: News, US, FDA, Government affairs, Human cell and tissue, Manufacturing, Quality, Regulatory intelligence, Regulatory strategy

Tags: CAR-T, Novartis, CTL019, gene therapy, cell therapy, ODAC

FDA Releases Annual Report on Biological Product Deviations By Michael Mezher - Published 28 June 2017

The US Food and Drug Administration's (FDA) Center for Biologics Research and Evaluation (CBER) on Wednesday released its annual summary of manufacturing deviations reported by biologics, blood and blood component, and human cells, tissues, and cellular and tissue-based products (HCT/P) manufacturers.

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

Tags: Deviations, CBER

New Texas Law on Stem Cell Treatments: Showdown With FDA Coming? By Zachary Brennan - Published 28 June 2017

With a new Texas law now in the books to allow companies to sell unproven stem cell treatments without US Food and Drug Administration (FDA) approval, some experts wonder when FDA will step in to shut down companies and clinics exposing people to unapproved medical products.

Categories: News, US, FDA, Clinical, Ethics, Government affairs, Human cell and tissue

Tags: Texas stem cell treatments, stem cells

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

Regulatory Business and Strategy, Medical Device Regulations, Adverse Event Reporting Requirements and a Preview of April By Gloria Hall - Published 05 April 2017

The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in April.

Categories: Features, Asia, Europe, Oceania, US, EC, FDA, Business Skills, Human cell and tissue, Medical Devices

Tags: Features, Regulatory Focus

Is the Current Regulation of Autologous Stem Cells Appropriate? By Dr. Ian Prosser - Published 29 March 2017

This article discusses the regulation of autologous stem cells and tissue therapies in Australia by addressing issues such as the safety and efficacy of cell therapies, which therapies are regulated, what regulators are doing in other countries and "next steps" in cell and tissue regulation.

Categories: Features, Japan, Europe, Oceania, US, EMA, FDA, MHLW, PMDA, TGA, Human cell and tissue

Tags: Autologous Stem Cells

Global Regulatory Developments in Cell and Gene Therapy, Drug Manufacturing Inspections, Regulatory Intelligence Tools and a Preview of March By Gloria Hall - Published 08 March 2017

The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in March.

Categories: Features, CFDA, EMA, FDA, Health Canada, ISO, Biologics and biotechnology, Human cell and tissue, Regulatory intelligence, Regulatory strategy

Tags: Regulatory Focus, Feature Articles, Feature Summary

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

MHRA Unveils 'Regulatory Ready' Stem Cell Lines By Michael Mezher - Published 27 February 2017

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Monday said it is looking to boost the development of cell therapies through the availability of what it calls "regulatory ready" embryonic stem cell lines.

Categories: News, Europe, MHRA, Clinical, Human cell and tissue

Regulation and Oversight of Gene Therapy in the US By Gregory Ramina - Published 27 February 2017

This article discusses the evolution, potential uses and regulatory aspects of gene therapy and includes funding, delivery mechanisms, bioethics and steps toward clinical trial implementation.

Categories: Features, US, FDA, Biologics and biotechnology, Human cell and tissue

Tags: Gene therapy,

EC Will Not Offer a Timeline for Phasing Out Non-Human Primate Research By Zachary Brennan - Published 17 February 2017

The European Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) released a preliminary opinion earlier this month reiterating the consensus that, when alternatives do not exist, appropriate use of non-human primates (NHPs) remains essential to some biomedical and biological research, as well as for the safety assessment of pharmaceuticals.

Categories: News, Europe, EC, Compliance, Crisis management, Drugs, Ethics, Government affairs, Human cell and tissue, Medical Devices, Preclinical

Tags: animal research, drug safety testing, non-human primates, European Commission Opinion

FDA Begins Accepting Regenerative Therapy Applications for RAT Designation By Zachary Brennan - Published 20 January 2017

The US Food and Drug Administration (FDA) on Thursday unveiled a new designation category created as part of the 21st Century Cures Act making drugs eligible for designation as a regenerative advanced therapy (RAT).

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

Tags: RAT designation, regenerative therapy, cell therapy, OTAT

Regulatory Recon: New Global Pharma Head for GSK; Pharma CEOs Discuss Trump (20 January 2017) By Zachary Brennan - Published 20 January 2017

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

Categories: News, Asia, Canada, Europe, US, EMA, FDA, Health Canada, NICE, Biologics and biotechnology, Combination products, Drugs, Human cell and tissue, Medical Devices

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Top FDA Officials Defend Agency Stance on Stem Cell Therapies By Michael Mezher - Published 01 December 2016

Officials from the US Food and Drug Administration (FDA) are defending its proposed approach to regulating stem cell therapies in response to criticism that doing so would slow access to such treatments.

Categories: News, US, FDA, Human cell and tissue

Tags: Stem cells

Final FDA Rule Reworks Import Data Submissions By Michael Mezher - Published 30 November 2016

The US Food and Drug Administration (FDA) on Tuesday issued a final rule requiring companies to submit data for FDA-regulated products via a new electronic system intended to serve as a "single access point" for imported products.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Human cell and tissue, Medical Devices

Tags: ACE, Automated Commercial Environment

Regulatory Explainer: 21st Century Cures Redux and What it Will Mean for FDA By Zachary Brennan - Published 28 November 2016

Lingering for more than two years, the revamped 21st Century Cures bill, unveiled in late November, has now been approved by the House and Senate and President Barack Obama has said he will sign it.

Categories: News, US, FDA, Biologics and biotechnology, Combination products, Compliance, Drugs, Government affairs, Human cell and tissue, In vitro diagnostics, Manufacturing, Medical Devices, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: 21st Century Cures, drug regulations, Congress and medical innovation, NIH, FDA innovation, Cures Now