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  • Regulatory NewsRegulatory News

    FDA's CBER Announces Plans to Release Guidances on Gay Blood Ban, Ebola and More

    The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) plans to release nearly a dozen guidance documents this year, including a massively anticipated document outlining planned changes to its "donor deferral policy" that now prevents most homosexual men from donating blood. FDA's guidance documents are its interpretations of regulations and legislation, which serve to "guide" persons or companies to a state of compliance. While t...
  • 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, ...
  • Regulatory NewsRegulatory News

    India’s CDCSO Establishes New Testing Requirements for Blood Glucose Strips

    India’s Central Drugs Standard Control Organization (CDSCO) is looking to tighten the regulation of blood glucose testing supplies, it announced last week. In a 7 August 2014 notice issued to all local State Drugs Controllers and port authorities, CDSCO ordered that importers and manufacturers of blood glucose test strips and analyzer based glucose reagents must provide three batches for testing at the National Institute of Biologicals in Noida.  Following the testin...
  • Regulatory NewsRegulatory News

    FDA to Focus on Blood, Platelet Disorders at Upcoming Meeting With Patients

    US regulators have announced they will soon hold their tenth patient-focused drug development meeting, this time focusing on a collection of blood and platelet disorders that includes hemophilia A, hemophilia B, and von Willebrand disease. Background The meetings are required under the Food and Drug Administration Safety and Innovation Act (FDASIA) , Section X of which called for the US Food and Drug Administration (FDA) to meet with patients in order to better un...
  • Regulatory NewsRegulatory News

    New Blood Clot Warnings Added to Labels of Testosterone Products

    The US Food and Drug Administration (FDA) yesterday said it will require manufacturers of testosterone products about an increased risk of venous blood clots, known as venous thromboembolism (VTE)—the latest warning for a class of drugs that has seen no shortage of scrutiny from regulators and researchers alike. Background Testosterone products, commonly used to treat low levels of testosterone in men, or "low-t," have long been associated with higher risks of so...
  • Hundreds of Comments Already in Hand, FDA Extends Comment Period for Duo of Diabetes Guidances

    The US Food and Drug Administration (FDA) has announced that it will extend the comment period for two recently released draft guidance documents intended to help the medical device industry to develop blood glucose monitoring devices intended for both home and point-of-care use. Background FDA's duo of draft guidances, released in January 2014, called for a new regulatory approach toward blood glucose test systems based on their location of use. Regulators cited the d...
  • 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...