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  • Regulatory NewsRegulatory News

    FDA and Pentagon Forge Breakthrough Designation Agreement

    Following the Pentagon’s criticism of the US Food and Drug Administration’s (FDA) sluggishness in approving a French freeze-dried plasma product, which some have said other countries’ troops have used for years, FDA and the Department of Defense’s (DoD) Office of Health Affairs on Tuesday launched a joint program to prioritize the efficient development of such medical products. The framework for the program was established, via H.R.4374 , after DoD sought to crea...
  • Regulatory NewsRegulatory News

    FDA Calls Out Unproven Claims of Unapproved Blood Device

    Earlier this month, the US Food and Drug Administration (FDA) released a letter sent to Dr. PRP America for claims made on its website for an unapproved medical device that the San Diego-based company claims can help concentrate and extract blood platelets, as well as adjust blood plasma levels. Mary Malarkey, director of the Office of Compliance and Biologics Quality at FDA’s Center for Biologics Evaluation and Research, wrote in the letter that a review of FDA’s databa...
  • Regulatory NewsRegulatory News

    EMA Releases Draft Guideline on Epidemiological Data Requirements for Plasma-Derived Products

    The European Medicines Agency (EMA) has released a draft Guideline on epidemiological data on blood transmissible infections intended to provide clarification on the data requirements for plasma-derived products. Background In the EU, companies must submit scientific data for blood- or plasma-derived medicinal products using the plasma master file (PMF) certification procedure. The requirement for PMF certification was established in Directive 2003/63/EC , which ...
  • Regulatory NewsRegulatory News

    New Report Looks at Challenges to Availability of Blood, Plasma in EU

    A new report from Creative Ceutical examines the availability of blood products in the EU and addresses some of the regulatory challenges impacting their supply. The report, An EU-wide overview of the market of blood, blood components and plasma derivatives focusing on their availability for patients , was commissioned by the European Commission’s Executive Agency for Health and Consumers (EAHC), and features commentary by stakeholders from various industry groups, pati...
  • Regulatory NewsRegulatory News

    FDA Clarifies Syphilis Screening Procedures for Blood, Plasma Donations

    • 28 August 2014
    • By
    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, ...
  • 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) , ...
  • 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...
  • 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 ...
  • 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...