OBJECTIVES: To describe reporting rates of gender-specific safety outcomes for new molecular entity (NME) drugs approved from the US Food and Drug Administration (US FDA) between 2009 and 2013 METHODS: New drug application (NDA) files for all NME drugs that were approved for systemic use in men and women were surveyed from the US FDA database. Specific reviews and key word searches were made for descriptions or tabulation of gender-specific inferential statistics on the drug safety section. The rates of inclusion of explicit descriptions or reports of statistical significance were calculated.   RESULTS: Of all 457 approved drugs during the study period, 118 NMEs were included for the evaluation.  Of those, 8 NMEs and 13 NMEs were excluded due to gender specific indications or non-systemic route of administration, respectively, thereby remaining 97 NME drugs were further reviewed. On average, gender-specific safety outcome descriptions were included in 74.2% (72/97) of the reviews. Gender-specific statistical significance was reported in 13% of the reviews. Format of the outcome descriptions was inconsistent varying from statement in the body text to table without descriptions.  CONCLUSIONS: About one in four NDA reviews for NMEs was lacking sufficient descriptions on gender-specific safety outcomes and the format of the safety outcome reports by gender was inconsistent.