Search Results for keywords:"sex-specific data"

The Food and Drug Administration (FDA) is releasing draft guidance on studying sex differences in the clinical evaluation of medical products. This guidance aims to improve the representation of females in clinical trials and provide recommendations for analyzing sex-specific data. It highlights the importance of understanding different responses to treatments based on sex to improve safety and effectiveness. The public is encouraged to submit comments on this draft guidance by April 7, 2025.

The Food and Drug Administration (FDA) has released a draft guidance document titled "Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies." This document aims to promote the inclusion and analysis of sex- and gender-specific data in medical device studies to ensure safety and effectiveness. Historically, females and nonbinary individuals have been underrepresented in clinical trials, leading to inadequate information about medical devices for these groups. The guidance encourages sponsors to incorporate diverse data in clinical studies and reporting, but it is currently not final and the public is invited to submit comments until April 7, 2025.