• Regulatory NewsRegulatory News

    Clinical trial diversity: Sponsors seek clarity on data sources, timing

    Drugmakers and clinician organizations praised the US Food and Drug Administration’s (FDA) recent draft guidance containing recommendations on developing a Race and Ethnicity Diversity Plan to improve enrollment of underrepresented racial and ethnic groups in clinical trials. But in public comments, they also called for greater details on the types of data that should be used to assess adequate enrollment of these populations, how these diversity plans should be applied to...
  • Feature ArticlesFeature Articles

    The RACE is on: Opportunities in pediatric oncology product development

    Pediatric oncology patients continue to have significant unmet medical need. Although the Pediatric Research Equity Act (PREA) mandated evaluation of new drugs for pediatric patients, the rarity and uniquity of pediatric cancers allowed for waivers or exemptions from PREA requirements. The passing of FDA Reauthorization Act amendments in 2017 included the Research Acceleration for Cure and Equity Act, which expands the scope of oncology products subject to PREA. Sponsors d...
  • Regulatory NewsRegulatory News

    FDA Updates Guidance on Collecting Race, Ethnicity Data in Clinical Trials

    The US Food and Drug Administration (FDA) recently updated its 2005 guidance detailing its expectations sponsors for collecting race and ethnicity data in clinical trials for drugs, biologics and medical devices. According to the agency, the guidance has been updated to reflect a standardized approach to collecting race and ethnicity data in accordance with requirements under the 2010 Affordable Care Act (ACA) and the 2012 Food and Drug Administration Safety and Inn...
  • Regulatory NewsRegulatory News

    FDA Unveils Policies Meant to Boost Safety, Efficacy of Medical Products for Women, Minorities

    The US Food and Drug Administration (FDA) has released new recommendations on the inclusion of women and other minorities in clinical trials, citing the need to better represent populations which have historically not been adequately included in clinical research. Background When the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law in 2012, among its many provisions was Section 907. The section required FDA to publish a report "addre...