title: Gender-specific Regulatory Challenges to Product Approval: a panel discussion.
abstract: 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.
authors.affiliation: Department of Emergency Medicine, Warren Alpert Medical School of Brown University, Providence, RI.
authors.forename: Alyson J
authors.initials: AJ
authors.lastname: McGregor
authors.forename: Helen
authors.initials: H
authors.lastname: Barr
authors.forename: Marna R
authors.initials: MR
authors.lastname: Greenberg
authors.forename: Basmah
authors.initials: B
authors.lastname: Safdar
authors.forename: Peter
authors.initials: P
authors.lastname: Wildgoose
authors.forename: David W
authors.initials: DW
authors.lastname: Wright
authors.forename: Judd E
authors.initials: JE
authors.lastname: Hollander
mesh_terms: D035843:Biomedical Research / Q000191:economics / Q000458:organization & administration* / Q000592:standards; D003257:Consumer Product Safety; D055808:Drug Discovery / Q000458:organization & administration; D004345:Drug Industry / Q000458:organization & administration; D004635:Emergency Medicine; D005260:Female; D005783:Gender Identity; D006801:Humans; D008297:Male; D011358:Product Surveillance, Postmarketing; D012107:Research Design; D012727:Sex Characteristics; D012737:Sex Factors; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration* / Q000592:standards