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Filtering on: "topics human cell and tissue"

Showing 1 – 25  of 47

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

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

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

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

FDA Withdraws Proposed Rule on Public Disclosure of Info on Unapproved Gene Therapies By Zachary Brennan - Published 10 November 2016

The US Food and Drug Administration (FDA) on Thursday announced it is withdrawing a proposed rule from 2001 that would have required the public disclosure of summaries of safety and effectiveness data, in addition to other information, from pre-market clinical trials of gene therapies and transplanted non-human tissues to humans, known as xenotransplantation.

Categories: News, US, CBER, Biologics and biotechnology, Clinical, Crisis management, Due Diligence, Government affairs, Human cell and tissue, Preclinical, Research and development

Tags: gene therapy, xenotransplantation, BIO, Public Citizen

Asia Regulatory Roundup: India’s DCGI Orders Manufacturers to Assess GMP, GLP Compliance (30 August 2016) By Nick Paul Taylor - Published 30 August 2016

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

Categories: News, Asia, CDSCO, CFDA, TGA, Biologics and biotechnology, Clinical, Crisis management, Drugs, Government affairs, Human cell and tissue

Tags: TGA, DCGI, GLP, GMP, stem cells

FDA Finalizes Guidance on Donor Screening to Reduce Hepatitis B Transmission By Michael Mezher - Published 18 August 2016

The US Food and Drug Administration (FDA) on Wednesday finalized its guidance on reducing the risk of hepatitis B virus (HBV) transmission via human cells, tissues and cellular and tissue-based products (HCT/Ps) by screening donors with nucleic acid tests (NAT).

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

Tags: Nucleic acid testing, NAT, Hepatitis B, HBV

Cancer Immunotherapies: EMA to Hold November Workshop By Zachary Brennan - Published 16 August 2016

The European Medicines Agency (EMA) on Tuesday announced that its Committee for Advanced Therapies (CAT) is organizing a workshop on 15 and 16 November 2016 to discuss the scientific and regulatory challenges of immunotherapy medicines based on genetically modified T-cells (white blood cells that fight off viruses and bacteria).

Categories: News, Europe, US, EMA, FDA, Business and Leadership, Clinical, Human cell and tissue, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: CAR T, CAR T-cell therapies, immuno-oncology, immunotherapy, EMA workshop on immunotherapies

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

What's Happening Down Under? The Australian Regulatory Scene in 2016 By Clive Simon, PhD, MBA - Published 13 June 2016

This article discusses the current regulatory framework for drugs and medical devices in Australia, compares differences in regulatory processes between Australia, the US and the EU and predicts future developments and challenges for industry and regulators.

Categories: Features, Oceania, TGA, Biologics and biotechnology, Cosmetics, Over the counter drugs, Prescription drugs, Human cell and tissue, In vitro diagnostics, Medical Devices, Veterinary products

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

Congressmen Question FDA Over Office of Laboratory Safety By Zachary Brennan - Published 19 May 2016

Rep. Fred Upton (R-MI), chairman of the House Energy & Commerce Committee, and Rep. Tim Murphy (R-PA) sent a letter to US Food and Drug Administration (FDA) Commissioner Robert Califf on Wednesday questioning why the agency has not formulated a budget request or specified a level of staffing for its Office of Laboratory Safety.

Categories: News, US, FDA, Crisis management, Government affairs, Human cell and tissue

Tags: bioresearch, lab safety, smallpox

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