• 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 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 Background The new draft guidance document relates to human cells, tissues and cellular and tissue-based products—better known by their acronym, HCT/Ps.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...
  • Regulatory NewsRegulatory News

    FDA Clarifies Syphilis Screening Procedures for Blood, Plasma Donations

    • 28 August 2014
    A new guidance document issued by the US Food and Drug Administration (FDA) finalizes an earlier draft set of recommendations on how blood and plasma collection centers can screen donors and samples for syphilis. Background Blood and plasma donations, like the donation of all cell and tissue products, are already subject to a battery of tests to ensure they are not contaminated with any serious diseases. At present, those tests include ones to detect hepatitis B and C, ...
  • Appeals Court Says Stem Cells May be Regulated as Drugs, Affirming Low Court's Decision

    The US District Court of Appeals for the DC Circuit has ruled that a lower court was correct when it ruled that the US Food and Drug Administration (FDA) could legally regulate stem cells as drugs. Background In July 2012, the US District Court of DC  ruled  that FDA may legally regulate stem cell therapies as drug products. The decision was viewed by many as an opening salvo in what was likely to be a lengthy court battle between the agency and a company accu...
  • Feature ArticlesFeature Articles

    The Second Anniversary of HPC, Cord Blood BLA Requirements – A Regulatory Review

    The use of hematopoietic (blood-forming) progenitor cells (HPCs) for transplantation is well established and thoroughly documented in the medical community. HPCs are adult stem cells that give rise to blood and immune cells. They can be sourced from bone marrow, peripheral blood and umbilical cord/placenta tissue and can renew, differentiate to a variety of specialized cells and undergo apoptosis (programmed cell death). The use of HPCs in nonclinical research dates back ...
  • Updated CBER Guidance Calls for New Methods to Detect West Nile Virus in Donated Blood, Tissue

    The West Nile virus (WNV) is a potentially deadly blood borne virus that, while native to Africa, has been introduced into the US within the last two decades. Now the US Food and Drug Administration (FDA) has announced a new guidance document intended to reduce the potential of the virus being transmitted through the donation of blood, cells, tissue or tissue-based products. Background Such donations are already regularly screened for a wide array of viruses, including...
  • FDA Challenges Another Company's Interpretation of HCT/P Regulations, Leading to Delays

    On 6 September 2013, the US Food and Drug Administration (FDA) released an Untitled Letter to a manufacturer of amniotic/chorionic-based products, saying it had run afoul of "minimal manipulation" regulations under 21 CFR 1271. Now the company is in effect conceding to FDA's contentions, suspending enrollment in a US-based clinical trial meant to support an eventual regulatory filing and commercialization of its products. Background On 5 September 2013, FDA's Center for...
  • Lawsuit: FDA Tissue Donation Regulations 'Unconstitutional'

    A woman is suing the US Food and Drug Administration (FDA) over its policy requiring potential sperm donors to undergo health testing before being allowed to donate, calling the regulations a violation of her constitutional rights. At issue for the woman-an Oakland, California resident known only as "Jane Doe" in the court filings-is whether she can use a trusted male friend as a sperm donor so she may start a family with her female partner without the interference of th...
  • 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...