• CBER Finalizes Two Guidance Documents on Use of Hematopoietic Progenitor Cells

    Two new guidance documents just released by the US Food and Drug Administration (FDA) finalize recommendations for Biologics License Applications (BLAs) and Investigational New Drug Applications (INDs) submitted in support of minimally manipulated placental or umbilical cord blood intended to help treat patients with hematopoietic system disorders. Hematopoeietic system disorders include ones affecting red blood cells (e.g. anemia), granulocytes (e.g. granulocytopenia), ...
  • 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)...
  • US Blood Donation Process to Become Easier for Recent Travelers to Cancun, Cozumel

    Malaria-a mosquito-borne disease common in some developing countries that kills hundreds of thousands of people each year-is a serious threat to the health of even healthy humans. But as a new guidance document released on 19 August 2013 by the US Food and Drug Administration (FDA) notes, the disease isn't just confined to the developing world. There is a risk, albeit a small one, of malaria being transmitted during blood transfusions-a risk FDA believes is no longer refl...
  • Draft Guidance Describes Change Notification Process for Blood Products

    A new draft guidance document released by the US Food and Drug Administration (FDA) regarding making approved human blood and blood components lays out the agency's recommendations on which changes to a product or its manufacturing processes will require notifications to be made to the agency, and how to do so in a least-burdensome manner. Three Main Types of Changes The guidance, released 31 May 2013, is specifically intended for manufacturers of licensed whole blood a...
  • Blood Establishment Computer Systems Must be Properly Validated, FDA Guidance Says

    A new final guidance document released by the US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) puts into place voluntary guidelines for blood establishments looking to validate the programs they use to keep track of their operations, including the donation of blood products. Background Even a cursory glance at the recall notices issued each week on FDA's website will show that blood products are phenomenally complex, as is the ...
  • Health, Defense and Industry Officials to Discuss Regulatory Challenges of Blood Products

    The US Food and Drug Administration (FDA) is planning to hold a meeting along with members of industry and various and diverse government agencies in April to work through issues related to the donation of blood and the regulation of blood products. The 10-11 April workshop, entitled "Application of Advances in Nucleic Acid and Protein Based Detection Methods to Multiplex Detection of Transfusion-Transmissible Agents and Blood Cell Antigens in Blood Donations," is intend...
  • Update of Blood and Plasma Guidance Calls for Revised Syphilis Screening Procedures

    • 27 February 2013
    A new draft guidance published by the US Food and Drug Administration (FDA) recommends revised screening procedures to guard against the threat of syphilis contamination in donated blood and plasma, taking a multi-pronged approach emphasizing redundant testing and risk mitigation methods. Background The draft guidance, Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis , notes ...
  • Final Guidance for Blood Product Testing Released by FDA

    The US Food and Drug Administration (FDA) has released a final guidance regarding the use of nucleic acid tests (NATs) to reduce the transmission of hepatitis B, part of a strategy the agency says it hopes will assist in the screening of blood and plasma donors for the virus. The final guidance comes nearly a year after the agency first released the draft version of the guidance . FDA said it considers Hepatitis B (HBV) NATs to be "necessary to reduce adequately and a...
  • Health Canada Updates CGMP Guidance for Biologics and Blood Products

    Health Canada has updated its current good manufacturing practices (CGMP) guidelines for Schedule D (biological) drugs and human blood and blood components. The updated guidance covers 13 distinct areas of CGMP compliance: Premises : Sets recommendations for manufacturing facilities, including screening areas for blood donors, secured quarantine storage and handling areas, separate areas for testing biological samples and storage requirements. Equipment : Sets rec...
  • 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: Tainted Blood Platelets Pose Greater Risk than HIV-Infected Blood Products

    There's a new top threat to the safety of the nation's blood supply.  The Wall Street Journal reports donated blood products containing bacterially contaminated blood platelets have usurped HIV for the status of the most potent threat to patients. Contaminated variants of platelets, which are used to clot blood, have been blamed in nearly two dozen deaths and hundreds of injuries in recent years. While testing is available to screen donated blood for contaminated...
  • FDA Releases Draft Guidance Changing Blood Donation Criteria

    The US Food and Drug Administration (FDA) has released new draft guidance intended to reduce the risk of transmitting malaria through donated blood. In its 6 June Federal Register posting, FDA said the draft guidance document addresses donor testing, as well as managing donor deferrals and reentry into the pool of blood donors. The purpose of the draft guidance is to "reduce the risk of transfusion-transmitted malaria," FDA wrote in the posting. "This draft guidance d...