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Gender-specific Regulatory Challenges to Product Approval: A Panel Discussion.
Academic Emergency Medicine : Official Journal of the Society for Academic Emergency Medicine
  • Alyson J McGregor, MD, MA
  • Helen Barr
  • Marna R Greenberg, DO, MPH, FACEP, Lehigh Valley Health Network
  • Basmah Safdar, MD
  • Peter Wildgoose
  • David W Wright
  • Judd E Hollander
Publication/Presentation Date

On May 13, 2014, a 1-hour panel discussion session titled "Gender-specific Regulatory Challenges to Product Approval" was held during the Academic Emergency Medicine consensus conference, "Gender-specific Research in Emergency Medicine: Investigate, Understand, and Translate How Gender Affects Patient Outcomes." The session sought to bring together leaders in emergency medicine (EM) research, authors, and reviewers in EM research publications, as well as faculty, fellows, residents, and students engaged in research and clinical practice. A panel was convened involving a representative from the Office of Women's Health of the U.S. Food and Drug Administration, two pharmaceutical executives, and a clinical EM researcher. The moderated discussion also involved audience members who contributed significantly to the dialogue. Historical background leading up to the session along with the main themes of the discussion are reproduced in this article. These revolve around sex- and gender-specific research, statistical analysis of sex and gender, clinical practice, financial costs associated with pharmaceutical development, adaptive design, and specific recommendations on the regulatory process as it affects the specialty of EM.

Peer Reviewed for front end display
Document Type
Citation Information

McGregor, A. J., Barr, H., Greenberg, M. R., Safdar, B., Wildgoose, P., Wright, D. W., & Hollander, J. E. (2014). Gender-specific Regulatory Challenges to Product Approval: a panel discussion. Academic Emergency Medicine: Official Journal Of The Society For Academic Emergency Medicine, 21(12), 1334-1338. doi:10.1111/acem.12531