• 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...
  • Regulatory NewsRegulatory News

    FDA Updates COA Compendium for First Time Since 2016

    As part of the US Food and Drug Administration’s (FDA) efforts to encourage more patient-focused drug development, the agency on Wednesday released an updated Clinical Outcome Assessment (COA) Compendium as a resource on a variety of different diseases and conditions. The compendium, which has been updated for the first time as part of an extension to a pilot COA Compendium that was launched in January 2016, can help companies understand how certain COAs have been used ...
  • Regulatory NewsRegulatory News

    Pharma Companies Call on FDA to Make Clinical Outcome Assessment Pilot More Useful

    More than a dozen drug developers, including Pfizer, Genentech, Sanofi and GlaxoSmithKline, and industry groups are calling on the US Food and Drug Administration (FDA) to ensure that a clinical outcome assessment (COA) pilot program includes more useful information for researchers. Background The pilot project, first proposed by FDA in January , is intended to help industry with a starting point for considering how certain COAs might be used in clinical trials and ear...
  • FDA Creates Program to Boost Regulatory Science, Speed Drug Development

    The US Food and Drug Administration (FDA) is announcing the launch of a new program that it hopes will help to advance clinical trial design and endpoints to boost regulatory science and facilitate expedited drug development. The program, which FDA is calling the Drug Development Tools (DDTs) Qualification Program, is being run by FDA's Center for Drug Evaluation and Research (CDER). The Center sees the program as "a mechanism for formal review by CDER to qualify drug de...