RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News

    Marks, Hahn confirm COVID vaccine EUA guidance coming

    The US Food and Drug Administration (FDA) will soon issue guidance on the data needed to support an emergency use authorization (EUA) for a vaccine to prevent coronavirus disease (COVID-19) according to Center for Biologics Evaluation and Research (CBER) Director Peter Marks.   Speaking at an event hosted by the Duke Margolis Center for Health Policy on Thursday, Marks hinted that additional guidance on EUAs for COVID-19 vaccines would be coming soon.   “You may ...
  • Regulatory NewsRegulatory News

    Marks on COVID-19 vaccine efficacy, EUAs and challenge trials

    A week after the US Food and Drug Administration (FDA) issued guidance on vaccines to prevent coronavirus disease (COVID-19), Peter Marks, director of the Center for Biologics Evaluation and Research, shed light on the reasoning behind the agency’s 50% efficacy threshold and where the agency stands on challenge trials and emergency use authorizations (EUAs).   Efficacy and approval   In its guidance, FDA said it expected sponsors to demonstrate a vaccine is at leas...
  • Regulatory NewsRegulatory News

    N-of-1 Trials: FDA Plots Path to Regulation

    The US Food and Drug Administration (FDA) is taking notice of a unique and recent phenomenon where physicians and specialists can create a tailored treatment to help or even cure an individual patient with a rare genetic mutation that could prove fatal. In an editorial published Tuesday in the New England Journal of Medicine , Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, and Peter Marks, director of the agency’s Center for Biologics Evalua...
  • Regulatory NewsRegulatory News

    Gottlieb, Marks Detail Plans to Advance Development of Cell and Gene Therapies

    US Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Biologics Evaluation and Research (CBER) Director Peter Marks on Tuesday detailed plans for the agency to keep pace with an expected influx of applications for cell and gene therapies over the coming years.   "The FDA is witnessing a surge of cell and gene therapy products entering early development, evidenced by a large upswing in the number of investigational new drug (IND) applications,...
  • Regulatory NewsRegulatory News

    Pazdur, Marks and Woodcock Discuss FDA Changes, What’s Coming

    Three of the US Food and Drug Administration’s (FDA) directors – Richard Pazdur, Peter Marks and Janet Woodcock – took the stage Wednesday at Prevision Policy’s Biopharma Congress to discuss all things FDA – from why the agency is viewed more positively now than in the past to what needs to happen in each of their centers. Center for Drug Evaluation and Research Director Woodcock said that the difference between years past, when FDA was viewed negatively, and now is tha...
  • Regulatory NewsRegulatory News

    FDA's Woodcock, Marks and Pazdur Talk Sustainability and New Approaches

    Three of the US Food and Drug Administration's (FDA) top experts sat together on a panel at the third Biopharma Congress in Washington, D.C. on Tuesday, discussing everything from where the agency is headed in the next several years, how the costly clinical trial system is not sustainable and how they interview prospective FDA employees. Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), reiterated a claim she made back in September ...
  • Regulatory NewsRegulatory News

    CBER Director Offers a Peek Into the Complexities of Where the Center is Headed

    In addition to protecting the US blood supply and ensuring vaccines are safe and effective, the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) is also now regulating complex gene and cell therapies, as well as a new category of treatments: regenerative medicines. Peter Marks, director of CBER, offered attendees of DIA’s annual conference on Tuesday a few examples of the changing landscape for the center, noting that with...
  • Pendergast, Pitts: Sebelius' Decision on Plan B Political, Step Down a 'Slippery Slope'

    Mary Pendergast, former US Food and Drug Administration (FDA) Deputy Commissioner under President Clinton, and Peter Pitts, the former FDA Associate Commissioner under President George W. Bush, offered scathing critiques of Secretary of Health and Human Services Secretary Kathleen Sebelius during an interview on 1 January 2012. Appearing on WUSA9's BioCenturyTV , Pendergast called the recent decision by Sebelius to overrule the FDA's decision in favor of less restrictiv...