• Regulatory NewsRegulatory News

    CDRH qualifies new LASIK patient-reported outcomes tool

    A new tool to measure patient-reported outcomes (PROs) for laser-assisted in situ keratomileusis (LASIK) corrective eye surgery has been qualified by the US FDA’s Center for Devices and Radiological Health (FDA’s CDRH).   “Patient-reported outcomes, such as visual symptoms and satisfaction with vision, are vital to understanding the potential outcomes that that can result from LASIK,” said William Maisel, director of the Office of Product Evaluation and Quality at CD...
  • Regulatory NewsRegulatory News

    FDA awards two COA grants to study neurodevelopment disorders and nephrotic syndrome

    The US Food and Drug Administration (FDA) announced the awarding of two grants under its Clinical Outcome Assessments (COAs) program to inform the selection of clinical trial endpoints for drugs to treat neurodevelopmental disorders (NDDs) and nephrotic syndrome.   The grants “provide avenues to advance the use of patient input as an important part of drug development that can foster innovation and the availability of safe and effective drugs,” said the agency’s 4 May ...