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  • 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...
  • Regulatory NewsRegulatory News

    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...
  • Feature ArticlesFeature Articles

    Genetically Engineered Foods and their Regulation: the Way Forward after Twenty Years of Adoption

    This article reviews the US history and impact of Genetically Engineered (GE) crops over two decades, explains the federal oversight of GE crops and suggests improvements to federal oversight to ensure the safety of GE crops and greater consumer confidence in GE foods. The article also discusses public attitudes toward GE foods and the issues surrounding the labeling of those foods, including the law requiring mandatory disclosure signed by President Obama on 29 July 201...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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 ...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    FDA Bans Import of Genetically Engineered Salmon

    The US Food and Drug Administration (FDA) has issued an alert banning the import of genetically engineered (GE) salmon, months after approving the first such animal as safe to eat. The import alert helps the agency comply with the FY 2016 omnibus spending bill President Obama signed into law in December. The law ordered FDA to block imports of GE salmon until the agency issues final guidance requiring food derived from GE salmon to be labeled as such. The law also requi...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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. ...
  • Regulatory NewsRegulatory News

    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...