• 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    A new draft guidance published by the US Food and Drug Administration (FDA) recommends revised screening procedures to guard against the threat of syphilis contamination in donated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 Background The draft guidance, Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis , notes ...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...
  • FDA: Blood Products Policy Guide 'Obsolete'

    The US Food and Drug Administration (FDA) has withdrawn its compliance policy guide (CPG) governing the registration of blood banks and other companies  that prepare human blood and blood products-the third such withdrawal made this week. In a Federal Register notice posted late on 26 June, FDA said it believes its 1974 CPG, Registration of Blood Banks, Other Firms Collecting, Manufacturing, Preparing or Processing Human Blood or Blood Products (CPG 7134.01) , ...
  • New Draft Guidance Establishes Special Controls for Blood Access Devices

    The US Food and Drug Administration (FDA) plans to reclassify and implement new special controls for blood access devices used in hemodialysis. In a 19 June 2012 Federal Register posting, FDA announced the release of its Draft Guidance for Industry and Staff: Class II Special Controls Guidance - Implanted Blood Access Devices for Hemodialysis , which it said serves "as the special control for implanted blood access devices." The draft guidance follows another Federal...
  • New Safety Warning Issued For Popular Birth Control Product, Potentially Rekindling Controversy

    The US Food and Drug Administration (FDA) issued an updated safety warning 10 April about birth control products containing drospirenone-a synthetic version of the hormone progesterone-saying the hormone may be associated with a higher risk for blood clots than other progesterone-based pills. Some studies highlighted by FDA showed a three-fold increase in the risk of developing a blood clot, though FDA admitted "it is unclear whether the increased risk seen for blood clo...
  • DHHS Reevaluating Blood Donation Rules

    The US Department of Health and Human Services (DHHS) is looking at the possibility of relaxing rules that currently prohibit gay men from donating blood or plasma. The guidelines have been in place since 1977 as a result of fears over "higher levels of certain transfusion-transmissible infections," but the policy has attracted significant amounts of controversy in recent years as blood safety testing experienced dramatic improvements. "As a result, questions have been ...
  • POGO Lambastes FDA Over Conflict of Interest Report

    The government watchdog group Project on Government Oversight (POGO) has aimed its sights on the US Food and Drug Administration (FDA) over reports that it allowed panelists with potential conflicts of interest to serve as voting members of an advisory committee, even as it took away the voting rights of a vocal critic of the product the advisory committee was voting on.p For further background, please see prior Regulatory Focus coverage here . The group, which calls ...
  • WSJ: Panel Assessing Bayer Birth Control Pills Had Ties to Company

    An advisory committee convened by the US Food and Drug Administration (FDA) to assess the safety of four Bayer AG birth control products had at least three members with ties to the company, according to The Wall Street Journal . The panelists, whose ties with Bayer included serving as consultants, speakers or researchers, did not have their ties to the company disclosed to the public by FDA. An FDA official, Jill Hartzler, told The Wall Street Journal that FDA ...