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  • 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    The US Food and Drug Administration (FDA) has withdrawn its compliance policy guide (CPG) governing the registration of blood banks and other companies  that prepare human blood and blood products-the third such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  • New Draft Guidance Establishes Special Controls for Blood Access Devices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 In a 19 June 2012 Federal Register posting, FDA announced the release of its Draft Guidance for Industry and Staff: Class II Special Controls Guidance - Implanted Blood Access Devices for Hemodialysis , which it said serves "as the special control for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 The draft guidance follows another Federal...
  • Blood Product Guidance Amended to Reflect New Disease Transmission Risks

    The US Food and Drug Administration (FDA) has released new guidance detailing how sponsors should include additional warnings on their products to reduce the risk of the transmission of Creutzfeldt-Jakob Disease (CJD). FDA last released a guidance on the topic in 2010, which made recommendations for labeling plasma-derived products to reflect the risks of CJD, which is a form of transmissible spongiform encephalopathy (TSE) spread through prions.  In its 11 June F...
  • EMA Switches to Electronic Submission for Plasma Product Applications

    The European Medicines Agency (EMA) announced this week the launch of a new electronic form for submitting plasma master file (PMF) application to the agency, replacing two existing forms. Plasma products are protein-based medicinal products typically utilized in blood transfusions, and are regulated by EMA . Sponsors looking to obtain certification for the plasma-based product must submit the PMF, which looks to control plasma source material, data and facilities inspe...
  • 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 ...
  • Revisions to Labeling Requirements for Blood Products Coming in July 2012

    The US Food and Drug Administration (FDA) is preparing to release revisions to their labeling requirements for blood and blood components, including source plasma, in July of 2012 according to a 3 January posting in the Federal Register . The rule will transition the system to one that uses machine-readable information that will act as a replacement for the "ABC Codabar" system that presently exists.  The final rule will also consolidate most of the labeling requir...