• Despite pandemic, CBER hit FY20 milestones

    The US Food and Drug Administration’s Center for Biologics Evaluation and Research (FDA’s CBER) met productivity milestones and continued product safety and biostatistics work, despite the pandemic disruptions of 2020. An annual report highlighting the fiscal year’s work, released 4 February, was accompanied by remarks from CBER director Peter Marks, MD, PhD.   Work plans for 2020 were upended as the COVID-19 pandemic swept the globe, said Marks. “This response has inv...
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    OCE year 4: Progress despite a pandemic

    Last year , the Oncology Center for Excellence laid out their vision for the future in the Project 2025 initiative, an ambitious effort to outline the future of cancer drug development and collaborate with stakeholders advance the field of oncology.   While the organization remains committed to Project 2025, they acknowledged efforts in 2020 soon shifted to address the needs of patients with cancer during the COVID-19 pandemic, according to Richard Pazdur, MD, directo...
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    J&J's COVID vaccine headed for VRBPAC on 26 February

    A third vaccine against COVID-19 is headed for review by the US Food and Drug Administration (FDA). On Thursday, the Janssen group of Johnson & Johnson submitted an application for emergency use authorization of its single-dose recombinant human adenovirus vaccine; FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is meeting to review the application on 26 February.   “A public discussion by the advisory committee members about the data submitt...
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    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...
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    Woodcock: FDA plans guidance to address new COVID-19 variants

    The US Food and Drug Administration is actively monitoring and assessing how current vaccines, therapeutics, and diagnostics are impacted by emerging COVID-19 variants and will issue guidance for ongoing medical product development against these variants.   In a recent statement, US Food and Drug Administration (FDA) acting commissioner Janet Woodcock, MD, said FDA has been monitoring potential new coronavirus variants since the start of the COVID-19 pandemic, and the ...
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    FDA's user fee reauthorization talks continue

    In ongoing negotiations, representatives from the generics drug industry continued their meetings with US Food and Drug Administration (FDA) representatives to discuss the upcoming reauthorization of the Generic Drug User Fee Amendments of 2017 (GDUFA) program. Additional rounds of meeting were held both before and after the start of the new year.   The meetings are closed to the public, and minutes are sparse on details. However, according to published minutes from ...
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    FDA Approvals Roundup: Tepotinib, Posimir, Gocovri

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Tepotinib gets accelerated approval for metastatic NSCLC Serono’s Tepmetko (tepotinib) has been granted accelerated approval for treating adults with metastatic non-small cell lung cancer (NSCLC) with MET exon 14 skipping alterations.   The kinase inhibitor was approved based on efficacy findings from the multicenter, nonrandomized, open-lab...
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    FDA outlines process for communicating record requests findings

    The US Food and Drug Administration (FDA) says it has put in place an interim process to communicate issues identified during record reviews done in lieu of or in advance of preapproval inspections with drugmakers and consider their responses before taking action on an application.   The agency says the interim process will continue throughout the COVID-19 public health emergency and may be extended to other drug inspection programs, including routine surveillance insp...
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    Analysis: Potentially high NDMA levels after ranitidine ingestion

    A new analysis showed elevated levels of the contaminant N-nitrosodimethylamine (NDMA) after the ingestion of ranitidine capsules across a range of physiologic conditions, with levels exceeding federal guidelines by several orders of magnitude in some conditions.   The study, conducted under conditions that simulate the human gastric environment, bolsters the U.S. Food and Drug Administration’s request in April 2020 for all ranitidine manufacturers to pull their prod...
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    CBER lays out scaled-down guidance agenda for 2021

    The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) has released its list of draft and final guidances it plans to issue in 2021.   The list contains just 14 guidances, half of which will be draft documents, down from 31 guidances in 2020 and 20 guidances in 2019. Of those 14 guidances, only a few are new additions to the list, with the remainder being carried over from the previous year.   CBER was able to cross more tha...
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    Inspections: GAO calls on FDA to plan for backlog, review alternatives

    In a nearly 350-page report to Congress on the federal government’s COVID-19 response, the Government Accountability Office (GAO) calls on the US Food and Drug Administration (FDA) to review its inspections approach and come up with a plan to address its looming backlog.   Pandemic inspection alternatives   In the early days of the pandemic, FDA halted non-mission-critical foreign and domestic inspections and relied on alternative tools, such as inspection reports ...
  • Stem cell and allergy clinics receive CBER untitled letters

    The US Food and Drug Administration’s Center for Biologics Evaluation and Research (FDA’s CBER) has issued untitled letters to a firm marketing regenerative medicine products and to a company selling extracts for immunotherapy.   On 25 January, CBER warned the owner of a California-based company called The Body Building, Inc. for marketing “BioGenix regenerative medicine products” to treat a variety of conditions including autoimmune disease, diabetes, Parkinson’s di...