Akbar, Mohammad, Ahn, Mee, Bashaw, Dennis, Blithe, Diana, Berry-Bibee, Erin, Davis, Daniel, Day, Ruth, Edelman, Alison, Hochel, Joachim, Huang, Shiew-Mei, Jamshidi, Roxanne, Kim, Myong-Jin, Kim, Na Hyung, Lee, LaiMing, Li, Li, Purohit, Vivek, Turpin, Jim, Scott, Pamela, Shon, Jihong, Soule, Lisa, Strauss, David, Sun, Haiying, Tassinari, Melissa, Tepper, Naomi, Willett, Gerald, Zhang, Lei, Zhang, Nan, Zhao, Ping and Yu, Chongwoo (2018) FDA Public Meeting Report on “Drug Interactions with Hormonal Contraceptives: Public Health and Drug Development Implication”. Journal of Clinial Pharmacology.

Abstract

Potential drug interactions with hormonal contraceptives (HCs) are an important public health concern. A public meeting on “Drug Interaction with Hormonal Contraceptives: Public Health and Drug Development Implication”1 was hosted by the United States (US) Food and Drug Administration (FDA). The meeting endeavored to provide an opportunity for the FDA to seek input from experts on the public health concerns associated with the use of HCs and interacting drugs that might affect efficacy and safety, including pharmacokinetic (PK) / pharmacodynamic (PD) considerations in designing drug interaction studies with HCs during drug development and approaches to translate the results of drug interaction information into informative labeling and communication. The input received could be used to refine FDA's thinking on HC drug interaction study design and interpretation, and labeling communication on drug interaction risk. This meeting benefited from strong and diverse participation from the Center for Drug Evaluation and Research (CDER) at the FDA, Center for Disease Control and Prevention (CDC), National Institute of Health (NIH), Medical Product Agency (MPA) of Sweden, pharmaceutical industry, and academia representatives. This report provides a summary of the key discussion based on the presentations and panel discussion.

Item Type:	Article
Keywords:	Drug interaction, hormonal contraceptive, labeling and communication, drug development
Date Deposited:	19 Mar 2019 00:45
Last Modified:	19 Mar 2019 00:45
URI:	https://oak.novartis.com/id/eprint/36250