Search Results for stem cells

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FDA Puts Opioids, Compounding, Stem Cells at Forefront of Enforcement Efforts By Zachary Brennan - Published 06 December 2017

The US opioid epidemic, drug compounding and the proliferation of stem cell clinics selling unproven treatments were highlighted as some of the focal points for US Food and Drug Administration (FDA) enforcement efforts last year and next year, officials said Wednesday at the Food and Drug Law Institute’s litigation and compliance conference in Washington, D.C.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs

Tags: opioids, FDA enforcement, FDA compliance, FDLI, stem cells

Asia Regulatory Roundup: India Tightens Stem Cell Guidelines (17 September 2017) By Nick Paul Taylor - Published 17 October 2017

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, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, stem cells, black triangle

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

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

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

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

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

EU's First Stem Cell Treatment Recommended by EMA By Michael Mezher - Published 07 January 2015

A major milestone in stem cell therapy was reached in December 2014 when a European Medicines Agency (EMA) committee recommended the conditional approval of Holoclar, the first stem-cell product to be recommended for approval in the EU.

Categories: News, Europe, EMA, Biologics and biotechnology, Human cell and tissue, Orphan products, Submission and registration

Tags: Holoclar, Chiesi, Stem Cells, CHMP, CAT, Holostem

Proposed DHHS Rule on Hemapoitic Stem Cells Show Why Regulatory Definitions Matter By Alexander Gaffney, RF News Editor - Published 03 October 2013

Categories: US, FDA

Tags: DHHS, stem cells

India Establishes Advisory Committee for Stem Cell Products and Cell-Based Therapies By Louise Zornoza, RegLink - Published 10 June 2013

Categories: Regulatory Update, India, CDSCO

Tags: MOHW, HCT/Ps, stem cells, cells

China Proposes Stem Cell Clinical Trial Rules By Louise Zornoza, RegLink - Published 08 March 2013

Categories: China

Tags: IRBs, Clinical Research, stem cells, clinical trials

Stem Cell-based Therapies and FDA Regulations By Trina Slabiak, MS, RAC - Published 01 November 2012

Stem cell-based therapies are arriving in the clinic as Phase 1 studies. Which technological challenges and US Food and Drug Administration (FDA) regulations govern the development and translation of stem cell therapies into medical treatments?

Categories: Features, FDA

Tags: Biotechnology, stem cells, regulation, clinical trials

Stem Cell Processor, IRB Targets of Related Warning Letters from FDA By Alexander Gaffney, RF News Editor - Published 17 October 2012

Categories: FDA

Tags: CellTex, Regenerative Sciences, 483, HCT/Ps, warning letter, Court, IRB, Latest News, stem cells, regulation

Former FDA Official Slams Regulation of Stem Cells as Exceeding Agency Authority By Alexander Gaffney - Published 09 August 2012

Categories: FDA

Tags: Regenerative Sciences, HCT/Ps, Court, Latest News, stem cells, regulation

US Court: Stem Cells may be Regulated as Drugs By Alexander Gaffney - Published 27 July 2012

Tags: Regenerative Sciences, US District Court, Court, Latest News, stem cells

Health Canada Approves World's First Stem Cell-Based Therapy By Alexander Gaffney - Published 21 May 2012

Categories: Health Canada

Tags: GvHD, Prochymal, Osiris Therapeutics, Stem-Cells, Therapy, Latest News, stem cells

Texas Approves New Stem Cell Therapies, Setting up Possible FDA Showdown By Alexander Gaffney - Published 16 April 2012

Categories: FDA

Tags: Showdown, Texas Medical Board, Perry, Texas, therapies, IRB, Latest News, stem cells