Web7 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 8 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 9 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible
Federal Register :: Diversity Plans To Improve Enrollment of ...
WebThe US Food and Drug Administration (FDA) recently announced new draft guidancefor life science companies on increasing diversity and inclusion in clinical trials to improve … WebMay 27, 2024 · This guidance, Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials, recommends that … clocktower village wa
6 ways to increase diversity in clinical trial …
WebFeb 21, 2024 · The FDA recommends a Race and Ethnicity Diversity Plan be submitted when: An Investigational New Drug (IND) or Investigational Device Exemption (IDE) submission is required. Clinical studies are intended to support a section 351(a) marketing submission for a Biologics License Application (BLA) or a section 505(b)(1) or (b)(2) … WebApr 15, 2024 · The draft guidance, “ Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials ,” recommends that sponsors develop and submit a Race and Ethnicity Diversity Plan (referred to as the “Plan”) to FDA before beginning clinical trials, based on a framework outlined in the guidance, … WebApr 14, 2024 · The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.” clock tower vinyl