JenkinsM, et al.Food and Drug Administration beyond the 2001 Government Accountability Office Report. Promoting drug safety for women. J Womens Health, 2021; 30:927–934.
2.
HeinrichJ. Most drugs withdrawn in recent years had greater health risks for women. Washington, DC: U.S. Government Accountability Office-01-286R, 2001.
3.
Drug products withdrawn or removed from the market for reasons of safety or effectiveness, 21CFR216.24.2018. Available at: https://www.federalregister.gov/documents/2018/12/11/2018-26712/list-of-drug-products-that-have-been-withdrawn-or-removed-from-the-market-for-reasons-of-safety-or Accessed February6, 2021.
4.
FDA. FDA action plan to enhance the collection and availability of demographic subgroup data. Washington, DC: FDA, 2014.
5.
GandhiM, AweekaF, GreenblattRM, BlaschkeTF. Sex differences in pharmacokinetics and pharmacodynamics. Annu Rev Pharmacol Toxicol, 2004; 44:499–523.
6.
WaxmanDJ, HollowayMG. Sex differences in the expression of hepatic drug metabolizing enzymes. Mol Pharmacol, 2009; 76:215–228.
7.
SoldinOP, MattisonDR. Sex differences in pharmacokinetics and pharmacodynamics. Clin Pharmacokinet, 2009; 48:143–157.
8.
PattiG, De CaterinaR, AbbateR, et al.Platelet function and long-term antiplatelet therapy in women: Is there a gender-specificity? A ‘state-of-the-art’ paper. Eur Heart J, 2014; 35:2213–2223.
9.
SanthraniT, NirmaladevisP. Effect of menstrual cycle phases on pharmacokinetics of Phenytoin in epileptic patients. Int J Pharm Technol, 3:2469–2509.
10.
ScottPE, UngerEF, JenkinsMR, et al.Participation of women in clinical trials supporting FDA approval of cardiovascular drugs. J Am Coll Cardiol, 2018; 71:1960–1969.
11.
FDA. FDA approves second drug to prevent HIV infection as part of ongoing efforts to end the HIV epidemic, 2019. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-second-drug-prevent-hiv-infection-part-ongoing-efforts-end-hiv-epidemic Accessed November30, 2020.
12.
FDA. Questions and Answers: Risk of next-morning impairment after use of insomnia drugs; FDA requires lower recommended doses for certain drugs containing zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist), 2018. Available at: https://www.fda.gov/drugs/drug-safety-and-availability/questions-and-answers-risk-next-morning-impairment-after-use-insomnia-drugs-fda-requires-lower Accessed November30, 2020.
13.
BradyE, NielsenM, AndersenJP, Oertelt-PrigioneS. Lack of consideration of sex and gender in clinical trials for COVID-19. medRxiv. Preprint. Available at: https://www.medrxiv.org/content/10.1101/2020.09.13.20193680v1 Accessed November28, 2020.