• Regulatory NewsRegulatory News

    Trump HHS advisor pressured FDA, says House subcommittee

    The House Select Subcommittee on the Coronavirus Crisis on Monday released nearly 100 pages of emails underscoring political pressure from a Trump administration official who pushed for the authorization of hydroxychloroquine and convalescent plasma to treat COVID-19.   Citing the emails, Subcommittee Chairman James Clyburn (D-SC) wrote to White House Chief of Staff Ronald Klain and Acting Health and Human Services Secretary Norris Cochran seeking additional docume...
  • Regulatory NewsRegulatory News

    FDA narrows convalescent plasma EUA

    The US Food and Drug Administration (FDA) on Thursday revised its emergency use authorization (EUA) for COVID-19 convalescent plasma to limit its use to high titer units and only in hospitalized patients who are in the early stages of the disease or who have impaired humoral immunity.   Convalescent plasma emerged as a potential treatment for COVID-19 in the early months of the pandemic. Initially, FDA facilitated its use through single patient emergency investigationa...
  • Regulatory NewsRegulatory News

    FDA explains convalescent plasma donor eligibility for COVID vaccine recipients

    The US Food and Drug Administration (FDA) last week revised its guidance on COVID-19 convalescent plasma to clarify when COVID-19 vaccine recipients can qualify as donors for plasma collected under the agency’s emergency use authorization (EUA) for convalescent plasma.   (RELATED: Lawmakers, experts raise questions after convalescent plasma EUA , Regulatory Focus 25 August 2020; COVID convalescent plasma guidance gets EUA updates , Regulatory Focus 3 Septembe...
  • Regulatory NewsRegulatory News

    Lawmakers, experts raise questions after convalescent plasma EUA

    After US Food and Drug Administration (FDA) Commissioner Stephen Hahn announced the issuance of an emergency use authorization (EUA) for convalescent plasma to treat coronavirus disease (COVID-19) alongside President Donald Trump on Sunday, experts and democratic lawmakers are raising concerns about how the announcement was presented and the perception of political pressure on the agency.   Convalescent plasma appears to meet the statutory standards for an EUA, which o...
  • 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
    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...