• Feature ArticlesFeature Articles

    MDR scope extension with human tissue: Regulatory implications and concerns

    Human tissue is newly introduced to the scope of the EU Medical Device Regulation (EU MDR). Although it offers the opportunity for uniform market access of device/tissue products, lack of clarity and borderline challenges remain and are centered on linking a harmonized device framework with a nonharmonized human tissue framework. Concerns include a shortage in the number of available notified bodies, decentralized regulatory oversight for tissues, and absence of an “Articl...
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    FDA Offers Accelerated Approval for 3rd Tissue-Agnostic Cancer Treatment

    The US Food and Drug Administration (FDA) on Thursday granted accelerated approval to Roche’s Rozlytrek (entrectinib), a treatment for adult and adolescent patients whose cancers have the specific genetic defect neurotrophic tyrosine receptor kinase (NTRK) gene fusion and for whom there are no effective treatments. This is the third time FDA has approved a cancer treatment based on a common biomarker across different tumor types rather than the location in the body wher...
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    EMA Unveils 19 Advanced Therapy Product Classifications

    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. The agency, through its Committee for Advanced Therapies (CAT), offers sponsors an optional consultation to determine whether a product meets the criteria for an advanced-therapy medicinal product (ATMP) . The classification procedure is laid out in Arti...
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    FDA Issues Guidance on Zika in Human Cell and Tissue Products

    The US Food and Drug Administration (FDA) on Tuesday announced new measures to prevent transmission of Zika virus via human cell and tissue products (HCT/Ps) by recommending a six-month deferral for at-risk donors. The virus, which has swept across Latin America and the Caribbean, is believed to be behind a spike in cases of microcephaly, a rare condition where an infant is born with an abnormally small head, and Guillain-Barré syndrome, a neurological disorder that can ...
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    FDA Sees Spike in Gene and Cell Therapy Applications

    The US Food and Drug Administration’s Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) met Tuesday to discuss updates of research programs in the Office of Cellular, Tissue and Gene Therapy (CTGT), which is part of FDA’s Center for Biologics Evaluation and Research (CBER). The research updates came as Raj Puri, MD, PhD, Director, Division of Cellular, and Gene Therapies (DCGT) at CBER told the committee that although his division has only licensed 12 prod...
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    FDA’s CBER Questions US Transplant Technology Company

    The US Food and Drug Administration (FDA) is taking issue with Arizona-based Pinnacle Transplant Technologies for manufacturing a number of proprietary amniotic membrane-based products that FDA believes should be classified and approved as biologics. Pinnacle, according to its website , currently manufactures and distributes morselized amniotic membrane-based products, which FDA says are intended to treat soft tissue injuries and inflammation, to cover and protect wou...
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    FDA Updates Adverse Event Reporting Requirements for Tissue, Cellular Products

    When you hear the term "adverse reaction" in the life sciences industry, you're likely to immediately think about pharmaceutical or medical device products. But as a new guidance document from the US Food and Drug Administration (FDA) makes clear, cellular and tissue products are also subject to reporting requirements. Background The new draft guidance document relates to human cells, tissues and cellular and tissue-based products—better known by their acronym, HCT/Ps. ...
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    FDA Outlines Regulatory Exemptions for Use of Cell, Tissue Products

    A new guidance document issued by the US Food and Drug Administration (FDA) is trying to clarify the differences between tissue products and procedures which fall under the agency's regulations, and those products and procedures which do not. Background FDA regulates tissue products—otherwise known as human cell, tissue or cellular or tissue-based products (HCT/Ps)—under Chapter 21, Section 1271 of the Code of Federal Regulations (21 CFR 1271). Specifically, FDA regul...
  • Warning Letter to Fertility Clinic a Crash Course in Tissue Donation Ethics

    The US Food and Drug Administration's (FDA) weekly batch of warning letters are often a cavalcade of depressing observations and alleged violations of every sort. But an April 2013 letter to Olympia Women's Health stands out for an ethical conundrum of sorts involving two patients trying to conceive a child while confronting the risk of transmitting a disease. Background Olympia is a Washington-based fertility clinic, according to the company's website . As a site that...
  • Average Time FDA Takes to Conduct HCT/P Facility Inspections on the Rise

    The US Food and Drug Administration (FDA) conducts thousands of regulatory inspections each year. While the media tends to devote much of its attention to some of the more high-profile inspections related to noteworthy drugs, medical devices and supplement products, the agency also conducts of hundreds of inspections related to human cell tissue and tissue-based products (HCT/Ps). Those facilities can often garner less attention than their larger, drug- and device-produc...
  • Australia Planning Updated GMPs for Blood and Tissue Products

    Australia's Therapeutic Goods Administration (TGA) is beginning the process of revising its code of good manufacturing practices (GMPs) for the manufacture of blood and tissue products, the agency announced on 11 September. The revisions will eventually update TGA's August 2000 code, GMPs for Blood and Tissues , and will involve a 12-month implementation period once finalized. TGA said it anticipates making two primary revisions to the code: a revised portion dea...
  • Report: Human Tissue Donation Rules Lack 'Inadequate Safeguards'

    • 18 July 2012
    An investigation into human tissue trafficking by The International Consortium of Investigative Journalists (ICIJ) has uncovered "inadequate safeguards" to protect consumers from poorly-sourced human tissue products. "Despite concerns by doctors that the lightly regulated trade could allow diseased tissues to infect transplant recipients with hepatitis, HIV and other pathogens, authorities have done little to deal with the risks," ICIJ wrote. "In contrast to tightly-mon...