• Regulatory NewsRegulatory News

    Rare Disease Clinical Trials: FDA Awards $15M in Grants

    After receiving 89 clinical trial grant applications, the US Food and Drug Administration (FDA) on Tuesday selected 12 projects that will be funded with more than $15 million over the next four years.   The announcement of the new funding comes as approximately 30 million Americans are affected by 7,000 known rare diseases, but only a few hundred treatments exist for these rare diseases.  Two-thirds of the 2019 grants will go to studies affiliated with universities,...
  • Regulatory NewsRegulatory News

    FDA Awards $4M in Grants to Support Development of COAs

    As part of the US Food and Drug Administration’s (FDA) work to develop publicly available Clinical Outcome Assessments (COAs), the agency awarded three grants to researchers at Albert Einstein College of Medicine, Duke University and Northwestern University. The grants, which total about $4 million, are meant to help collect patient input to inform the selection of clinical outcomes and how data is collected. “If methodologically sound data collection tools are devel...
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    Rare Diseases: FDA Awards Grants for 21 Clinical, Natural History Studies

    The US Food and Drug Administration (FDA) on Friday awarded $32 million in research grants to fund 15 clinical studies and six natural history studies for rare diseases. The grants are being funded through FDA's orphan products grants program , with $22 million going to the clinical studies and $9.8 million in combined funding from FDA and the National Center for Advancing Translational Sciences' (NCATS) Therapeutics for Rare and Neglected Diseases program going to fund...
  • Regulatory NewsRegulatory News

    FDA Helps Fund 21 Early Phase Trials for Rare Disease Treatments

    The US Food and Drug Administration (FDA) on Monday announced it is awarding $23 million in research grants for 21 new clinical trials over the next four years to boost the development of rare disease treatments. The grants, awarded to researchers from academia and industry at domestic and international clinical sites, are part of FDA’s Orphan Products Clinical Trials Grants Program, created in 1983, which has provided more than $370 million (including $19 million ...
  • FDA Grant to Support Neglected Orphan Disease Trials

    The US Food and Drug Administration (FDA) is looking to help fund the development of products intended to treat orphan diseases in areas where no treatments currently exist or the existing treatments are inferior. In a Federal Register post on 3 August, FDA noted the grant money will total $14.1 million, with $4.1 million going toward the development of between five and 10 new awards during the first year and the remaining $10 million supporting continuation awards...