• Regulatory NewsRegulatory News

    CBER Q&A addresses stem cell enforcement questions

    The US Food and Drug Administration (FDA) issued a question-and-answer document on Monday to address issues that may arise now that the agency's enforcement discretion policy against unauthorized marketing of these products has come to an end.   The agency’s Center for Biologics Evaluation and Research (CBER) ended a period of enforcement discretion against purveyors of unauthorized human cells, tissues, or cellular or tissue- based products (HCT/Ps) on 31 May 2021. Ac...
  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Deviation Reporting for HCT/Ps

    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. The 20-page guidance, first drafted in December 2015 , includes additional examples and editorial changes to improve clarity from the draft. ...
  • Regulatory NewsRegulatory News

    CBER Calls on HCT&#47P Manufacturers to Report Adverse Events Within 15 Days

    The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) on Tuesday issued new guidance to provide establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps) with recommendations for complying with the requirements for investigating and reporting adverse reactions involving communicable diseases. CBER notes that examples of HCT/Ps that are subject to adverse reaction reporting and fall with...
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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...
  • Anvisa Unveils New Adverse Event Database

    Brazil's national regulatory agency, Anvisa, has unveiled a new database that will gather information on adverse events relating to blood products, tissues, cells and organs.  The database, which was developed by Italy's National Transplant Center, already includes more than 900 adverse event reports related to cell therapies, organ donations, and assisted reproduction, among others.  The database was first unveiled at the World Health Organization's (WHO)...
  • India Establishes Advisory Committee for Stem Cell Products and Cell-Based Therapies

    India's Ministry of Health and Welfare (MOHW) issued an order on 3 June 2013 establishing a High Powered Committee to advise it on the regulation of stem cell products and other cell based therapies. The Committee will consist of four members, including a representative from the stem cell industry, and must submit a report with its recommendations to the Ministry within two months.  The terms of reference for the Committee include: Reviewing the current status o...
  • 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...
  • Stem Cell Processor, IRB Targets of Related Warning Letters from FDA

    The US Food and Drug Administration (FDA) is continuing to enforce a controversial policy involving the regulation of stem cell therapies, which the agency defends as enforcing established authority but critics have derided as the regulation of the practice of medicine. A 24 September warning letter to Texas-based CellTex Therapeutics Corporation references the firm's use of adipose tissue (lipoaspirate) recovered from donors, which is then isolated and cultured into adi...
  • 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...
  • Former FDA Official Slams Regulation of Stem Cells as Exceeding Agency Authority

    Should the US Food and Drug Administration (FDA) have the authority to regulate cells derived from-and later put back into-a person? A recent opinion-editorial published in The Wall Street Journal by former FDA Associate Commissioner Scott Gottlieb and Coleen Klasmeier , head of FDA practice at the law firm Sidley Austin LLP, argues FDA's efforts to increase regulatory enforcement against stem cell manufacturers has the potential to backfire against the nascent an...
  • FDA Warning Letter Cites Company for Breaking HCT/P Regulations

    A warning letter sent to the company Young Medical Spa by the US Food and Drug Administration (FDA) cites the company for violating minimal manipulation regulations governing the use of human cells, tissues or cellular and tissue-based products (HCT/Ps). FDA's warning letter specifically cites Young's Owner and Medical Director Thomas E. Young for removing, reprocessing and injecting patients with their own adipose tissue (lipoaspirate), from which Young isolated stem ce...