Gender-specific Regulatory Challenges to Product Approval: A Panel Discussion.

Publication/Presentation Date

12-1-2014

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.

Volume

21

Issue

12

First Page

1334

Last Page

1338

ISSN

1553-2712

Disciplines

Emergency Medicine

PubMedID

25443664

Peer Reviewed for front end display

Peer-Reviewed

Department(s)

Department of Emergency Medicine, Department of Emergency Medicine Faculty

Document Type

Article

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