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  • Feature ArticlesFeature Articles

    Strengthening the regulatory profession through resilience and diversity

    This article explores the importance of resilience and diversity specific to the regulatory profession in preventing burnout and enhancing overall regulatory capability within an organization. The author addresses existing tools for  functional capability-building and supplemental considerations when intentionally building resilience into regulatory functions.   Introduction Regulatory affairs, or in many cases, a combined functional department named “regulatory an...
  • Feature ArticlesFeature Articles

    Fostering diversity and talent: A Pfizer case study

    The Pfizer Global Regulatory Affairs (GRA) – Howard University College of Pharmacy (HUCOP) Advanced Pharmacy Practice Experience (APPE) program fulfills a requirement of the Doctor of Pharmacy (PharmD) curriculum and helps students explore biopharmaceutical industry career options and prepare for their career after graduation, such as pursuing postgraduate training and seeking employment. The HUCOP Preceptorship Program at Pfizer was designed to broadly increase awareness ...
  • Regulatory NewsRegulatory News

    Older adults, Black patients underrepresented in post-marketing studies

    In postmarketing studies of cancer therapies approved by the US Food and Drug Administration (FDA), representation of older adults and Black patients does not appear to be improved compared with premarketing studies, a recent investigation in JAMA Network Open suggests.   In addition, the sex and race of participants were identified less frequently in postmarketing studies than premarketing studies, according to a cross-sectional analysis of 77 premarketing and 56 po...
  • Regulatory NewsRegulatory News

    How to reduce bias, improve fairness in medical devices

    Lessons learned in the artificial intelligence community about addressing bias could also be applied to medical devices, according to a recent perspective in the journal Science .   “Initiatives to promote fairness are rapidly growing in a range of technical disciplines, but this growth is not rapid enough for medical engineering. Although computer science companies terminate lucrative but biased facial recognition systems, biased medical devices continue to be sold a...
  • Regulatory NewsRegulatory News

    Clinical trial diversity: FDA pushes real-world evidence, diffusion of trial sites

    Real-world evidence, post-marketing studies, and migrating clinical trial sites into underserved communities are all strategies the U.S. Food and Drug Administration (FDA) is pushing to help increase data on the outcomes of minority patients, according to Amy Abernethy, MD, PhD, the agency’s principal deputy commissioner.   “There is real a gap between the makeup of our American public and the representation of our Black community and Black women in clinical trials,” A...