Harmonization of Regulatory Approaches for Evaluating Therapeutic Equivalence and Interchangeability of Multisource Drug Products: Workshop Summary Report

Regulatory approaches for evaluating therapeutic equivalence of multisource (or generic) drug products vary among different countries and/or regions. Harmonization of these approaches may decrease the number of in vivo bioequivalence studies and avoid unnecessary drug exposure to humans. Global harmonization for regulatory requirements may be promoted by a better understanding of factors underlying product performance and expectations from different regulatory authorities. This workshop provided an opportunity for pharmaceutical scientists from academia, industry and regulatory agencies to have open discussions on current regulatory issues and industry practices, facilitating harmonization of regulatory approaches for establishing therapeutic equivalence and interchangeability of multisource drug products

FDA Public Meeting Report on “Drug Interactions with Hormonal Contraceptives: Public Health and Drug Development Implication”

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